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INSIDE FRONT COVER
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TABLE OF CONTENTS
Table of Contents
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Surgical Technique At-a-Glance
2
Preoperative Planning
4
Preparation of the Femur
5
Preparation of the Tibia
13
Preparation of the Patella
23
Trial Reduction and Final Component Selection
28
Final Bone Preparation
32
Final Component Implantation
34
Final Check and Closure
38
Instrument List
39
Implant List
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Note: Please refer to the Product Insert (Instructions for Use) for important information
pertaining to the product description and handling, indications for use, warnings and
precautions, possible adverse effects and contraindications.
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APEX KNEE™
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SURGICAL TECHNIQUE
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APEX KNEE™
Preoperative Planning
High quality radiographs are extremely important for
precise preoperative planning.
Full length A/P and lateral extremity roentgenograms
should be obtained and the mechanical and anatomic
axis identified. These axes are useful in establishing the
plane of the distal femoral resection and tibial resection.
It is helpful to draw the femoral and tibial resection lines
on the films as an intra-operative reference.
If intramedullary alignment is to be used to establish the
plane of the tibial resection, the correct entry point on
the tibial plateau for insertion of the intramedullary tibial
resection guide should be identified. Full length films
should be available to check placement of the IM rod.
Radiographic templates are provided to permit
preoperative estimation of implant size. The templates
are overlaid on the x-ray films (Fig. 1 and Fig. 2). It
is recommended to check the magnification of the
radiographs in order to choose the right size of the
radiographic templates to be used. The APEX Knee
System is also present in several digital radiographic
systems.
fig. 1
The size of the femoral component in the lateral view
is of particular importance since under-sizing will
result in laxity in flexion as well as greater potential for
notching of the anterior femoral cortex. Over-sizing can
create tightness in flexion and increase the potential for
increased excursion of the quadriceps mechanism.
The APEX Knee tibial component system permits the
use of tibial inserts one size higher, same size or any size
lower than the Tibial Baseplate size. This allows the use
of the Tibial Baseplate with the best possible coverage
of the tibial plateau with an insert that best matches the
femoral component. In all cases, the numerical size of the
tibial insert should match that of the femoral component,
including the “plus” sizes. For example, a size 2 tibial
insert should be used with a size 2 or size 2+ femoral
component.
Note: The APEX Knee System adapts to the surgical
technique of any surgeon. For the purposes of this surgical
technique, the preparation of the femur is used as the starting
point of the procedure.
fig. 2
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SURGICAL TECHNIQUE
Opening the Intramedullary Canal
The Starter Drill should be used to drill a hole in the
distal femur coaxial with the femoral endosteal canal. The
entry point should be just anterior to the insertion of the
ACL (Fig. 3).
This drill is stepped to provide clearance for the IM Rod
without the need to “wobble” the drill.
fig. 3
After opening the canal with the Starter Drill (Fig. 4),
carefully insert the IM rod into the femoral canal,
establishing the anatomic axis of the femur. Once
satisfied with the position, remove the IM rod.
Note: It is recommended that the IM Rod is inserted parallel
to the femoral axis in the sagittal view to avoid, for example,
implanting the femoral component in flexion.
fig. 4
Hint: Careful flushing and suctioning of the canal can reduce
the incidence of embolization.
fig. 5
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APEX KNEE™
Assembly of the
Femoral Alignment Guide
Set the valgus angle on the Distal Femoral Alignment
Guide by turning the dial to the correct angle based
upon preoperative planning for a precise distal femoral
alignment. Settings of 3°, 4°, 5°, 6°, and 7° are available.
The Distal Femoral Cut Block has two holes that mate
to the pins on the quick connector of the Distal
Femoral Alignment Guide. The quick connector
automatically clips into place (Fig. 6a).
fig. 6a
Insert the Intramedullary Rod through the Distal
Femoral Alignment guide and into the femoral canal.
The alignment guide should be brought into contact with
the distal condyles (Fig. 6b).
If both condyles are in contact with the guide, or the
worn condyle is missing by the estimated thickness of
the cartilage, this will serve as verification that the correct
valgus angle has been selected to carry out the final
distal femoral resection. Take note that the neutral line
of the Distal Femoral Alignment Guide is parallel to an
imaginary line which joins the posterior condyles.
fig. 6b
The Distal Femoral Alignment Guide’s vertical rods
allow the Distal Cut Block to be positioned in contact
with the femur, minimizing the excursion of the saw
blade.
fig. 7
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SURGICAL TECHNIQUE
Distal Femoral Resection
The Distal Femoral Cut Block is secured to the femur
with Headless Drive Pins through the pin holes on the
black neutral line (Fig. 8). The preferred initial position
for the pins is marked “0”.
This pin position allows the block to be relocated in the
distal or proximal direction in 1 mm increments. In the
neutral (“0”) position, 9 mm of distal bone is resected
through the slot of the block, which is equal to the
thickness of the femoral component.
fig. 8
If the desired resection is more or less than 9 mm,
this can be adjusted in 1 mm increments by utilizing
additional holes in the block.
In the case of a femoral deformity, or a patient with a
prosthetic hip, checking the extramedullary alignment
may be required. In this case, place the Universal Handle
in the anterior key hole of the Distal Femoral Cut Block.
The Alignment Check Rod can be dropped through the
Universal Handle to locate the center of the femoral
head (Fig. 9).
fig. 9
Once the alignment has been checked, the Femoral
Distal Cut Block is secured by inserting at least one
Headless Drive Pin through the block’s converging
pin holes. This will reduce the block movements while
the distal femoral resection is carried out, ensuring the
accuracy of the cuts.
It is important to use a 1.27 mm (0.050”) blade thickness
in order to ensure the precision of the cut. After
performing the resection, the Angel Wing may be used
to verify that the resected surfaces of the condyles are flat
and coplanar. If necessary, refinements of the distal cut
can be made (Fig. 10).
fig. 10
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APEX KNEE™
Femoral Rotational Alignment
The proper rotational alignment of the femoral
component is critical to a successful outcome. In
particular, care must be taken to ensure that the
component is not internally rotated, as this can adversely
affect patella tracking and the quadriceps mechanism.
Place the A/P Femoral Sizer on the resected distal femur.
Set the sizing guide so that the posterior reference feet
are in contact with the posterior condyles (Fig. 11); if one
of the condyles is deficient, the guide should be rotated
to a position that compensates for the defect.
Posterior Referencing
fig. 11
The rotation of the femoral component is determined by
drilling through the desired 3.2 mm holes in the Sizer
with the provided Spade Tip Drill Bit. Neutral (0°), 3°or
5° external rotation may be selected.
Epicondylar Axis, Whiteside’s Line
Mark Whiteside’s line along the sulcus of the patellar
groove in the femur. Position the Femoral Sizer on the
resected distal femur. With the medial foot of the Sizer
in contact with the posterior medial condyle, rotate the
Sizer until the 0° holes are parallel the epicondylar axis.
Whiteside’s line should be visible through the central slot
in the Sizer to verify rotation. Drill through the 0° holes
using the provided Spade Tipped Drill Bit.
fig. 12
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SURGICAL TECHNIQUE
Femoral Sizing
Set the stylus to the size measured during preoperative
planning. This places the stylus tip at the correct anterior
saw blade exit point. Place the stylus on the anterior
cortex, midway between the highest and lowest points
(Fig. 13).
The size will be indicated on the gauge on the front of
the A/P Femoral Sizer. If the indicated size is different
from the stylus setting, reset the stylus and recheck the
size.
It is recommended to use the Angel Wing through the
front slots of the A/P Femoral Sizer to determine the
appropriate size and to verify that the anterior cortex
will not be notched (Fig. 14). The APEX Knee System
uses a posterior reference to improve ligament balance in
flexion.
fig. 13
fig. 14
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APEX KNEE™
Femoral Sizing (cont.)
The Sizer allows the drill holes to be shifted anteriorly
by one or two mm. This is accomplished by rotating the
knob to the desired position. This may be desirable when
the patient is between sizes and the surgeon prefers to
downsize the component without notching.
The wings of the M/L Sizing Guide allow an
approximation of the M/L femoral component size to be
used when assembled to the A/P Femoral Sizer
fig. 15
Note: Often, especially in female patients, the ideal M/L
component size may be smaller than the component that
matches the A/P size specified by the sizing guide.
The APEX Knee System includes “+” size components with a
narrower M/L dimension, but the same A/P size as standard
components. For example, an APEX 2+ femoral component
has the same A/P box cuts as a size 3, but with the same M/L
size as a standard size 2 component.
fig. 16
As a result, there is usually no need to downsize the box cut
and/or shift the box cut anterior to compensate for potential
M/L overhang due to an oversize component.
Pilot holes for the femoral cutting blocks are made
through the 0°, 3° or 5° holes in the Femoral Sizer using
the Spade Tipped Shoulder Drill (Fig. 17).
Note: Often, especially in female patients, the ideal M/L
component size may be smaller than the component that
matches the A/P size specified by the sizing guide.
fig. 17
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SURGICAL TECHNIQUE
Femoral Resections
The appropriate size 4-in-1 Femoral Cutting Block
is placed on the distal femur by driving the block pins
into the previously drilled holes (Fig. 18).
Note: Do not strike the face of the 4-in-1 Femoral Cutting
Block with the mallet or damage to the saw capture slots may
occur. Use the tibial or femoral impactor to seat the resection
block.
fig. 18
Additional stability of the block can be obtained by
using: one Universal Handle in each side of the block
(Fig. 19) and/or by driving two pins into the converging
holes provided. For the resection, is important to use an
oscillating saw blade of 1.27 mm (0.050”).
fig. 19
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APEX KNEE™
Femoral Resections (cont.)
Remove the 4-in-1 Femoral Cutting Block (Fig. 20) by
assembling the round tip of the Slap Hammer to the
slot on the front side of the block. At this point, the
preparation of the femur is finished.
The selection of the components to be used can be
delayed until the final trial reduction (examples: CR
femoral component: with Congruent tibial insert or with
Ultra Congruent tibial insert; PS femoral component:
with PS tibial insert, etc.).
If it has pre-operatively been decided to use a PS femoral
component, see Step 4 of the trial reduction and component
final selection.
fig. 20
Note: It is strongly recommended not to drill the holes for
the CR/CS Femoral Component Trial pegs until the final
trial reduction has occurred and the final M/L position of the
component has been determined.
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SURGICAL TECHNIQUE
Alignment, Resection, and
Tibial sizing
The APEX Knee System offers both intramedullary and
extramedullary alignment options for tibial resection.
Extramedullary Tibial Alignment
Assembly, stabilization and distal alignment
of the extramedullary tibial guide
The Ankle Clamp should be placed on the anterior tibia.
The Ankle Clamp is secured by placing the blue paddles
around the ankle, just proximal to the malleolae.
Center the Extramedullary Tibial Guide over the ankle
joint, using the depression between the extension hallicus
longus and the extension digitorum longus tendons as
a landmark (Fig. 21). In most cases, the guide will be
slightly medial to the central mark of Up-Rod.
In the sagittal plane, the Extramedullary Tibial Guide
should be aligned parallel to a line extending from the
center of the knee joint to the center of the ankle joint.
fig. 21
With alignment adjustments complete, the independent
A/P and M/L locking knobs are turned clockwise to
secure the assembly.
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APEX KNEE™
Extramedullary Tibial Alignment (cont.)
Assembly, stabilization, and proximal alignment
of the extramedullary tibial guide
The Slope Setter and Tibial Cutting Block can be used
with 2 different Up-Rods depending upon surgeon
preference.
Option 1
Use of the slope setter with the tibial alignment
up-rod (Ref #15b1)
The Up-Rod is connected to the Ankle Clamp. The
Slope Setter is connected to the Up-Rod and to the
Tibial Cut Block of the corresponding knee (Fig. 22).
In the M/L plane, the guide shaft should be aligned with
the long axis of the tibia. Normally, this will result in
the long axis of the guide intersecting the middle of the
tibial plateau.
fig. 22
The guide is positioned in rotation by aligning the distal
A/P positioning shaft with the second toe. If there is
an ankle deformity, align it with the anterior tibial
tuberosity. It can be useful to place a Steinman Pin in the
center slot of the Tibial Cut Block (Fig. 23) to provide
initial M/L stabilization of the block but still permit A/P,
varus/valgus, and slope adjustment of the assembly.
fig. 23
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SURGICAL TECHNIQUE
Option 2
Use of the spiked up-rod (Ref #15b2)
The Spiked Up-Rod is connected to the Slope Setter and
to the Tibial Cut Block of the corresponding knee (L/R)
(Fig. 24).
In the M/L plane, the Extramedullary Guide shaft must
be aligned with long axis of the tibia. It can be helpful
to start by partially driving the longer of the two locking
spikes into the tibia to provisionally fix the guide, while
still allowing for additional adjustment of rotation, and
to a lesser extent, varus/valgus position.
The guide is positioned in rotation by aligning the distal
A/P positioning shaft with the second toe. If there is
an ankle deformity, align it with the anterior tibial
tuberosity.
Once the appropriate rotation and varus/valgus position
has been established, the position of the guide can be
fixed by driving both pins of the spiked guide into the
tibial plateau.
fig. 24
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APEX KNEE™
Posterior Slope
In general, the existing posterior slope of the tibial
plateau should be reproduced by the proximal tibial
resection. This will usually be around 4°. To establish the
tibial slope, there are two main methods using the
Up-Rod:
a) To reproduce the native slope of the tibia, begin with
the extramedullary guide adjusted for rotation, varus/
valgus, and M/L position, with the slope setter adjusted
to the 0° position. With the locking bolt loose, the
J-Hook or the Angel Wing can be inserted through
the Tibial Cut Block, and used to preliminarily set the
resection level.
fig. 25
The posterior slope may then be adjusted by loosening
the thumb wheel on the ankle clamp. This permits
anterior-posterior movement of the distal end of the
shaft until the J-Hook or the Angel Wing matches the
slope of the healthy tibial plateau. Finally, once the tibial
slope has been set, the guide position should be locked in
place.
b) The guide shaft must be adjusted by the long axis of
the tibia on the A/P plane. Afterwards, the Slope Setter
is adjusted to the required A/P slope using the adjusting
knob (Fig. 26). Normally, this angle is around 4°.
fig. 26
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SURGICAL TECHNIQUE
Intramedullary Tibial Alignment
Preparation of Intramedullary Tibial Guide
The Starter Drill is used to gain entry into the
intramedullary canal. The entry point usually lies between
the tibial spines (in M/L view) and slightly anterior to
the anterior origin of the spines (in A/P view) (Fig. 27).
After opening the intramedullary canal with the Starter
Drill (Fig. 28), the Intramedullary Rod should pass easily
into the canal (Fig. 29). If not, the position of the entry
hole should be checked and modified if needed.
Hint: Careful irrigation and suctioning can reduce the
potential for embolization.
fig. 27
Preparation of Intramedullary
Tibial Guide
Insert the Intramedullary Rod into the Intramedullary
Tibial Guide and insert the Intramedullary Rod into
the intramedullary canal. Assemble the shaft of the
Intramedullary Tibial Guide to the Slope Setter, and the
Tibial Cut Block of the corresponding knee.
For rotational alignment, it is necessary to insert the
Alignment Fork in the two lower holes of the Tibial Cut
Block. The Alignment Rod can be inserted through the
holes of the Universal Handle after it is mated to the
Alignment Fork.
fig. 28
fig. 29
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APEX KNEE™
The Intramedullary Tibial Guide must be aligned in
rotation with the second toe. If there is a foot or ankle
deformity, it can be aligned with the tibial tubercle. Once
rotational alignment has been established, the stabilizing
teeth may be tapped into the tibial plateau, stabilizing
the guide (Fig. 30).
The tibial slope is then adjusted by setting the required
A/P slope on the knob of the Slope Setter (Fig. 32).
Typically, this angle is around 4°.
fig. 31
fig. 30
fig. 32
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SURGICAL TECHNIQUE
The Tibial Stylus is inserted through the resection slot
of the Tibial Cut Block. The Tibial Stylus has two tips:
representing 0 mm and 10 mm resection measurements.
If the surgeon chooses to measure resection depth from
the least affected side of the tibial plateau, the tip of the
stylus marked as 10 mm should be placed on the center
of the least affected area of the articular surface. This will
produce a 10 mm resection.
If the surgeon chooses to from the most affected side of
the tibial plateau, the tip of the stylus marked “0 mm”
should be placed on the center of the most affected
area of the articular surface (Fig. 33a and 33b). This will
produce a resection at the level of the greatest defect.
fig. 33a
Once the resection height has been determined, the
locking knobs should be tightened to ensure the Tibial
Cut Block is secured during the next step.
fig. 33b
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APEX KNEE™
Placement of the Tibial Resection
Block and Final Check of Proximal
Tibia Resection Height
Once correctly positioned, the Tibial Cut Block is fixed
with Steinman Pins (Fig. 34a and 34b). These pins
should be placed in the neutral pin holes, highlighted by
a darkened line.
The block can be adjusted proximally or distally in 2 mm
increments to increase or decrease the level of the tibial
resection.
After the block is fixed, the IM Tibial Guide is unlocked
and removed for a final verification of alignment. This
final check is done by inserting the Universal Handle,
while connected to the Alignment Paddle, into the lower
pin holes of the block.
fig. 34a
The Alignment Check Rod can then be inserted through
one of the holes in the Universal Handle and used to
check alignment (Fig .35).
fig. 34b
fig. 35
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SURGICAL TECHNIQUE
Final Placement and Resection
Once the established alignment is considered correct,
the pins are inserted into the Tibial Cut Block and the
Tibial Guide is retracted. To improve Tibial Cut Block
stabilization, converging pins may be used.
It is important to use a 1.27 mm (0.050” ) oscillating saw
blade for the resection to get a precise cut.
After the resection, the Angel Wing can be used to
ensure that the resected surfaces are flat and coplanar. If
needed, refinements of the resection should be made.
The Alignment Rod should be oriented inward towards the
ankle during the final alignment check (Fig. 37).
fig. 36
fig. 37
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APEX KNEE™
Sizing the Resected Tibia
The resected tibial surface is sized using the Tibia Tray
Trials. The Universal Handle is placed on the Tibia Tray
Trial. The Alignment Rod is then dropped through it
to check the alignment with the center of the ankle
(Fig. 38).
The surgeon should use the largest Tibia Tray Trial
that fits within the borders of the resected tibial surface
without any overhang.
For a better bone coverage, the APEX Knee System
includes right and left Tibial Baseplates.
Note: The APEX Knee System offers an innovative system
of femorotibial congruence. Once the size of the femoral
component has been selected, the size of the tibial insert must
be of the same size. However, the Tibial Baseplate can be:
one size below the femur size, the same size than the femur,
or any size larger than the femur. Thus, it ensures the most
anatomical coverage without compromising an optimal
articular congruence.
fig. 38
The selected Tibia Tray Trial is kept in place using two
Headed Pins through the anterior pin holes.
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SURGICAL TECHNIQUE
Patella Sizing
The APEX Knee System offers two methods of patella
resection: Using the Patella Resection guide, or the Patella
Reaming System.
Note: For the purpose of this surgical technique, the Patella
Resection Guide will be discussed first. The use of the Patella
Reaming System will be outlined later in the technique.
Patella thickness is measured using the Patella Caliper
(Fig. 39).
The thickness of the patella prosthesis in the APEX Knee
System is either 8 mm or 10 mm.
fig. 39
Note: It is recommended that the remaining thickness of the
patella is at least 12 mm to avoid excessive weakening.
Resecting The Patella
The Patella Resection Guide for the APEX Knee System
provides accurate, repeatable measurement of patella
resection (Fig. 40). As the patella is clamped in the
jaws of the Resection Guide, the amount of resection
is read from the resection stylus. Swing the stylus to be
perpendicular to the body. It can be moved up and down
to see the desired resection. Swing back to lock in place.
Note: The Patella Resection Guide saw capture slots
accommodate a .050” (1.27 mm) saw blade.
fig. 40
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APEX KNEE™
Drill Peg Holes
The holes for the 3 pegs on the patella are prepared using
the Patella Clamp with Drill Guide loaded (Fig. 41).
Size is read from the concentric rings on the bushing
(Fig. 42) and may be confirmed using the Patella Sizing
Guide. The hole pattern is the same for all sizes of
patella.
The Patella Trial is pressed into place and final trialing of
the components is completed.
Note: The Patella Post Drill is grey to avoid mistaking for
the black Femoral Post Drill
fig. 41
fig. 42
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SURGICAL TECHNIQUE
Reaming the Patella Resection
The Patella Reamer Basket of the previously measured
diameter is assembled to the Patella Clamp Assembly.
Meanwhile, the patella is kept in place and stabilized
(Fig. 43).
Note: It is recommended not to overtighten to avoid damage
to the patella.
fig. 43
Then, the selected diameter of the Patella Reamer (1) is
assembled to the Patella Reamer Shaft (2) and Patella
Reamer Depth Stop (3) (Fig. 44).
The assembly is dropped into the Patella Reamer Basket
until the Patella Reamer makes contact with the highest
point of the original patella.
3
2
1
fig. 44
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APEX KNEE™
Reaming the patella (cont.)
At this point, the Patella Reamer Depth Gauge is
inserted onto the Patella Reamer Shaft Assembly,
making contact with the Reamer Basket (Fig. 45a and
45b).
The Patella Reamer Depth Stop can now be lowered
until contact with the Depth Gauge is made. The depth
of the patella ream will depend on whether you chose
the 8 or 10 mm Depth Gauge.
Once the Depth Stop is fixed in position, the Depth
Gauge can be removed, and reaming can commence.
Be sure the power drill is set to the reaming speed.
fig. 45a
Note: The Depth Gauge should be always positioned in this
order because reaming height will be always depend on the
patella height.
fig. 45b
26
SURGICAL TECHNIQUE
Drill Peg Holes
Once the patella has been reamed, a same size Patella
Reamer Drill Guide is passed through the Patella
Reamer Basket (Fig. 46).
Three holes are drilled for the patellar component pegs
using the Patella Post Drill (Fig. 47).
fig. 46
fig. 47
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APEX KNEE™
Trial Reduction and Final
Component Selection
Surgeon preferences vary concerning the sequence of
implant placement. The APEX Knee System does not
require that a specific implant placement sequence be
followed.
Note: Additionally, Flexion/Extension Spacers are included
to check the flexion/extension gaps and ligament balance
before the use of the trial components
fig. 48a
Femoral Trial Placement
The chosen CR Femoral Trial is placed on the cut femur
(Fig. 48a) using the Femoral Inserter (Fig. 48b).
When the correct positioning of the femoral component
trial has been achieved, the trial is fully seated using the
Femoral Impactor Pad and the Impactor Handle
(Fig. 48c).
fig. 48b
Note: It is recommended not to drill the holes for the CR
femoral component pegs until final trial reduction.
fig. 48c
28
SURGICAL TECHNIQUE
Component Selection
Tibia Tray Trial Placement
Once the correct alignment of the components has been
established, the Tibia Tray Trial is placed and fixed in its
position using the Universal Handle and two Headed
Pins. To set the rotation of the Tibia Implant, it is
helpful to make two marks with the electrocautery at
the insertion level of the Universal Handle (Fig. 49).
fig. 49
Tibial Insert Trial Placement
A Tibial Insert Trial of the same size of the chosen
Femoral Component Trial is placed on the Tibia Tray
Trial using the Insert Trial Forceps (Fig. 50).
When the posterior cruciate ligament has been sacrificed
or is not working properly, the Ultra Congruent Insert
Trial should be used (Fig. 51).
Patella Trial Placement
The chosen Patella Component Trial is placed into the
holes previously drilled in the patella (Fig. 52) by using
the Insert Trial Forceps .
fig. 50
fig. 51
fig. 52
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APEX KNEE™
Component Selection
Tibia Tray Trial Placement
Knee extension and flexion stability must be checked.
The extension stability must be carried out with the
knee flexed several degrees to relax the posterior capsule.
However, the knee should be able to completely extend.
The flexion check must be developed with the knee in a
flexion angle of 90°. Most appropriate stability is reached
when the medial and lateral gaps are similar to a healthy
knee during the tension application in both valgus and
varus positions.
Mobility Check
The knee should be able to completely extend without
the application of any force. To check the knee flexion
the surgeon should elevate the thigh and allow gravity
to flex the leg. This will give an appropriate indication of
how much flexion can be achieved.
Patella Track Check
During the mobility check, the patella should slide on
the patellar groove smoothly, with little or no pressure on
its lateral border and without the need to be stabilized
medially.
In case of lateral subluxation, the lateral retinaculum
should be released.
30
SURGICAL TECHNIQUE
Component Selection
Re-adjustments
If the flexion and extension gaps are not balanced, it
could be necessary to adjust the tibial and/or femoral
resection level. To modify the posterior femoral resection
level (since the APEX Knee System is based on a
posterior reference, independent of the size), the Femoral
Repositioning Block is inserted into the holes drilled for
the 4-in-1 Femoral Cutting Block pegs which allows
variation of the posterior resection level by 1 or 2 mm
(Fig. 53).
fig. 53
Note: In case of M/L instability or if the surgeon prefers to
use the PS femoral component, see the next section.
Preparation of PS Femoral Component
For the PS knee, the cavity for the femoral box must be
prepared. Start by positioning the Box Reamer Guide
on the resected femur, using Steinman Pins to fix the
PS Reamer guide in place. The PS Reamer guide is
most stable when 3 pins are used for fixation.
For this procedure, PS Box Reamer is used in
conjunction with the PS Reamer Drive (Fig. 54a) to
ream the PS Box Cut using the appropriate PS Reamer
guide (Fig. 54b).
fig. 54a
Note: The PS Reamer Guide allows for final adjustment of
the M/L positioning. Care should be taken to assure that the
PS Reamer Guide sits flush to the bone prior to performing
the reaming operation.
Trial PS Reduction
Using the Femoral Inserter, the PS Femoral Trial
Component of the same size of the femoral component
is inserted. Once again, the stability and mobility are
checked.
fig. 54b
31
APEX KNEE™
Femoral Bone Preparation
When using a CR femoral component, and after
satisfactory trial reduction, the holes for the final femoral
component are made. This is done using the Femoral
Post Drill through the corresponding distal holes of the
Femoral Component Trial (Fig. 55).
When using a PS femoral component, this step is not
necessary; bone preparation is now complete.
Tibial Bone Preparation
fig. 55
Once the Tibia Tray Trial is firmly pinned into place,
the Keel Punch is used to create the cavity for the tibia
component’s keel.
The Keel Punch Dart of the size corresponding to the
implant chosen should be loaded into the Keel Punch
Handle. This is achieved by depressing a button on the
distal end of the punch, and releasing it to fix the dart
into place. (Fig. 56)
fig. 56
32
SURGICAL TECHNIQUE
Tibial Bone Preparation (cont.)
Prior to striking the Tibial Punch, check that the distal
face of the punch is flat against the tibial trial. This will
assure that the cavity for the keel will be created at the
proper angle. The punch can then be impacted until the
Punch Dart is fully seated (Fig. 57a and 57b).
Once the bone bed is prepared, retract the guide.
fig. 57a
fig. 58
33
fig. 57b
APEX KNEE™
Final Component
Implantation
The APEX Knee System does not require a specific
preparation sequence. To describe this surgical technique,
these are the steps to follow:
It is recommended a pulsed lavage is used to manage an
effective cleaning of the trabecular bone.
Tibial Baseplate Implantation
If a cemented Tibial Baseplate is used, the cement should
be mixed and placed on both the resected tibial surface
and the Tibial Baseplate by hand or with a syringe. The
tray should be placed in the correct orientation following
the previously defined steps and be fully seated by using
the Tibial Baseplate Impactor and the Impactor Handle
(Fig. 59).
All excess cement should be cleaned from the edges of
the tibial component, moving from posterior to anterior.
It is also possible to use the porous Tibial Baseplates
without cement when the PS Knee is not being used.
fig. 59
Note: This technique depicts the implantation of the Tibial
Baseplate separately from the Tibial Insert although it could
be implanted at the same time.
34
SURGICAL TECHNIQUE
Final Component
Implantation
Femoral Component Implantation
The APEX Knee System includes cemented and noncemented femoral components.
In the case of using cemented components, a cement
layer should be applied to the femoral resected surfaces
and to the femoral component in contact with the bone.
Note: To avoid excessive posterior cement extrusion, the
quantity of cement to be applied in the femoral posterior
surface and in the femoral component should be limited.
fig. 60a
The final femoral component should be guided by
the Femoral Inserter (Fig. 60a). Once the component
positioning has been properly achieved, it is finally
inserted using the Femoral Impactor Pad and the
Impactor Handle (Fig. 60b).
If cement has been used, any excess should be cleaned
from the prosthesis edges. The prosthetic surface should
be meticulously free of cement or other debris.
fig. 60b
35
APEX KNEE™
Final Component
Implantation
Femoral Component Implantation
(cont.)
If cement has been used, upon inserting the femoral
component, a Tibia Insert Trial of the same size can be
placed on the final Tibial Baseplate (Fig. 61). The knee
should then be brought into full extension and held in
position as the cement cures. Any additional cement
that is extruded during cement compression should be
removed at this time.
Once the cement has hardened, the knee is brought back
into flexion and the tibial trial is removed.
fig. 61
Tibial Insert Implantation
All extraneous cement must be removed from the
borders of the Tibial Baseplate. The surface of the
Tibial Baseplate should be meticulously cleaned prior to
placement of the tibial insert.
The tibia insert slides onto the Tibial Baseplate in the
anterior to posterior direction. The rails on the Tibial
Baseplate engage the grooves on the bottom of the
Tibia Insert (Fig. 62).
Note: The APEX Knee System is designed to be used with
the same femoral component and tibial insert size to ensure a
high congruency. Tibial Baseplates of one size smaller, same
size or any size larger than the femoral component can be
used in order to offer a high anatomic adaptability.
fig. 62
36
SURGICAL TECHNIQUE
Final Component
Implantation
Locking Bolt Implantation
The Tibia Tray Locking Bolt may be inserted at this time
and threaded into the Tibial Baseplate (Fig. 63). If the
locking screw does not thread easily into the hole, first
check that the tibial insert has been completely pushed
onto Tibial Baseplate. Also check for debris that may be
obstructing the insertion of the screw.
Note: Do not attempt to perform final tightening of the
Tibial Baseplate Locking Bolt at this time.
The patella surface and the back of the patella
component should be coated with cement. The patella
component is then attached to the patella.
fig. 63
The Patella Cementing Clamp is then joined to the
Patella Clamp and both are used to compress the patella
component firmly onto the patella (Fig. 64).
Note: Care must be taken to avoid excessive compression
as this may damage the patella.
Excess cement should be removed.
Final Tightening of Locking Screw
Once the cement has hardened, the final tightening of
the Tibial Baseplate Locking Bolt is performed. With
the knee in flexion, the Torque Wrench is used to achieve
the final tightening of the bolt.
fig. 64
Note: Turn until the first calibration lines(60”/lbs) are
aligned (Fig. 65).
fig. 65
37
APEX KNEE™
Final Check and Closure
A final check should be performed prior to closure.
Any remaining excess cement should be removed.
Final assessment of alignment, stability, range of
motion, and patella tracking should be performed
(Fig. 66).
Closure
Closure is performed as preferred by the surgeon.
fig. 66
38
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
1
620502
STARTER DRILL
2
WS-10060
INTRAMEDULLARY ROD
3
WS-10050
DISTAL FEMORAL CUT
ALIGNMENT GUIDE
4
WS-10030
DISTAL FEMORAL CUT BLOCK
5
WS-30053
PIN DRIVER
6a
KS-80012
STEINMAN PIN
6b
KS-80021
THREADED PIN
6c
WS-20058
HEADED PIN
7
WS-20057
PIN PULLER
39
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
8
WS-30071
UNIVERSAL HANDLE
9
WS-30072
ALIGNMENT ROD
10
WS-10071
A/P FEMORAL SIZER
11
WS-10069
M/L SIZING GUIDE
12
WS-30090
ANGEL WING
13
WS-10120
SPADE TIPPED SHOULDER DRILL – ZIMMER
14
WS-10001 to
WS-10006
4-IN-1 CUTTING BLOCK
15a
WS-20060
EXTRAMEDULLARY TIBIAL GUIDE
40
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
15b1
WS-20055
UP-ROD
15b2
WS-20055
SPIKED UP-ROD
16
WS-20082
SLOPE SETTER
17
WS-20002
WS-20003
TIBIA CUTTING BLOCK
18
WS-20054
STYLUS
19
WS-30074
ALIGNMENT FORK
20
KS-81010
J-HOOK
21
WS-20076
INTRAMEDULLARY TIBIAL GUIDE
22
KS-99250
PATELLA CALIPER
41
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
23
WS-40001
PATELLA DRILL GUIDE
24
WS-40015
PATELLA CLAMP
25
WS-40071
PATELLA RESECTION GUIDE
26
KS-99120
KS-99121
KS-99122
PATELLA REAMER BASKET
27a
KS-99223
PATELLA REAMER SHAFT ASSEMBLY
27b
KS-99222
PATELLA REAMER DEPTH
STOP ASSEMBLY
28
KS-99130 to
KS-99134
PATELLA REAMER
29
WS-40066
PATELLA REAMER DEPTH GAUGE
30
KS-99233 to
KS-99235
PATELLA REAMER DRILL GUIDE
31
KS-99210
PATELLA POST DRILL
42
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
32
KS-29510 to
KS29516
FLEXION/EXTENSION SPACERS
33
WS-10020
FEMORAL REPOSITIONING BLOCK
34
K2-1410R
K2-1420R
K2-1425R
K2-1430R
K2-1435R
K2-1440R
K2-1445R
K2-1450R
K2-1460R
FEMORAL TRIAL SIZE 1 - RIGHT
FEMORAL TRIAL SIZE 2+ - RIGHT
K2-1410L
K2-1420L
K2-1425L
K2-1430L
K2-1435L
K2-1440L
K2-1445L
K2-1450L
K2-1460L
FEMORAL TRIAL SIZE 1 - LEFT
FEMORAL TRIAL SIZE 2+ - LEFT
35
KS-61108
FEMORAL INSERTER
36
WS-1051
FEMORAL IMPACTOR PAD
37
710300
IMPACTOR HANDLE
43
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
38
WS-30060
SLAP HAMMER
WS-2111R
TIBIAL TRAY TRIAL SIZE 1 - RIGHT
WS-2112R
WS-2113R
WS-2114R
WS-2115R
WS-2116R
WS-2111L
TIBIAL TRAY TRIAL SIZE 1 - LEFT
WS-2112L
WS-2113R
WS-2114R
WS-2115R
WS-2116R
40
KS-39000
INSERT TRIAL FORCEPS
41
WS-20124 to
WS-20126
KEEL PUNCH DART
42
WS-20123
KEEL PUNCH HANDLE
43
700350
FEMORAL POST DRILL
39
44
DIAGRAM
INSTRUMENT LIST
REF #
44
PRODUCT NUMBER
DESCRIPTION
WS-35110
CONGRUENT INSERT TRIAL SZ 1 X 10MM
WS-35111
WS-35112
WS-35114
WS-35116
WS-35120
WS-35121
WS-35122
WS-35124
WS-35126
WS-35130
WS-35131
WS-35132
WS-35134
WS-35136
WS-35140
WS-35141
WS-35142
WS-35144
WS-35146
WS-35150
WS-35151
WS-35152
WS-35154
WS-35156
WS-35160
WS-35161
WS-35162
WS-35164
WS-35166
45
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
44
WS-36110
WS-36111
WS-36112
WS-36114
WS-36116
WS-36118
WS-36119
WS-36120
WS-36121
WS-36122
WS-36124
WS-36126
WS-36128
WS-36129
WS-36130
WS-36131
WS-36132
WS-36134
WS-36136
WS-36138
WS-36139
WS-36140
WS-36141
WS-36142
WS-36144
WS-36146
WS-36148
WS-36149
WS-36150
WS-36151
WS-36152
WS-36154
WS-36156
WS-36158
WS-36159
WS-36160
WS-36161
WS-36162
WS-36164
WS-36166
WS-36168
WS-36169
DESCRIPTION
ULTRA INSERT TRIAL SIZE 1 X 10MM
46
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
DESCRIPTION
45
KS-40298 to
KS-40388
PATELLA TRIAL
46
WS-20151
TIBIAL TRAY IMPACTOR
47
WS-40020
PATELLA CEMENTING CLAMP
48
KS-3100
TORQUE WRENCH
49
KT-00001 to
KT-00006
PS REAMER GUIDES
50a
KS-66001, KS-66002,
KS-66003
PS BOX REAMERS SIZE A-C
50b
KS-66010
PS REAMER DRIVE
51
KT-0010R
KT-0020R
KT-0025R
KT-0030R
KT-0035R
KT-0040R
KT-0045R
KT-0050R
KT-0060R
KT-0010L
KT-0020L
KT-0025L
KT-0030L
KT-0035L
KT-0040L
KT-0045L
KT-0050L
KT-0060L
PS FEMUR TRIAL SZ 1 RIGHT
PS FEMUR TRIAL SZ 2+ RIGHT
PS FEMUR TRIAL SZ 1 LEFT
PS FEMUR TRIAL SZ 2+ LEFT
47
DIAGRAM
INSTRUMENT LIST
REF #
PRODUCT NUMBER
52
KT-01100
KT-01110
KT-01120
KT-01140
KT-01160
KT-01180
KT-01200
KT-02100
KT-02110
KT-02120
KT-02140
KT-02160
KT-02180
KT-02200
KT-03100
KT-03110
KT-03120
KT-03140
KT-03160
KT-03180
KT-03200
KT-04100
KT-04110
KT-04120
KT-04140
KT-04160
KT-04180
KT-04200
KT-05100
KT-05110
KT-05120
KT-05140
KT-05160
KT-05180
KT-05200
KT-05100
KT-06110
KT-06120
KT-06140
KT-06160
KT-06180
KT-06200
DESCRIPTION
PS INSERT TRIAL SIZE 1 X 10MM
48
DIAGRAM
IMPLANT LIST
REF #
PRODUCT NUMBER
52b
KT-11100
KT-11110
KT-11120
KT-11140
KT-11160
KT-11180
KT-11200
KT-12100
KT-12110
KT-12120
KT-12140
KT-12160
KT-12180
KT-12200
KT-13100
KT-13110
KT-13120
KT-13140
KT-13160
KT-13180
KT-13200
KT-14100
KT-14110
KT-14120
KT-14140
KT-14160
KT-14180
KT-14200
KT-15100
KT-15110
KT-15120
KT-15140
KT-15160
KT-15180
KT-15200
KT-15100
KT-16110
KT-16120
KT-16140
KT-16160
KT-16180
KT-16200
DESCRIPTION
PS-C INSERT TRIAL SIZE 1 X 10MM
49
DIAGRAM
IMPLANT LIST
PRODUCT NUMBER
DESCRIPTION
KP-0010L
PS FEMUR, CEMENTED, SIZE 1, LEFT
KP-0020L
KP-0025L
PS FEMUR, CEMENTED, SIZE 2+, LEFT
KP-0030L
KP-0035L
KP-0040L
KP-0045L
KP-0050L
KP-0060L
KP-0010R
PS FEMUR, CEMENTED, SIZE 1, RIGHT
KP-0020R
KP-0025R
PS FEMUR, CEMENTED, SIZE 2+, RIGHT
KP-0030R
KP-0035R
KP-0040R
KP-0045R
KP-0050R
KP-0060R
DIAGRAM
50
IMPLANT LIST
PRODUCT NUMBER
DESCRIPTION
DIAGRAM
KC-1101L
CR FEMORAL COMPONENT, SIZE 1, LEFT, NON-POROUS
KC-1101R
CR FEMORAL COMPONENT, SIZE 1, RIGHT, NON-POROUS
KC-1102L
KC-1102R
KC-1125L
CR FEMORAL COMPONENT, SIZE 2+, LEFT, NON-POROUS
KC-1125R
CR FEMORAL COMPONENT, SIZE 2+, RIGHT, NON-POROUS
KC-1103L
KC-1103R
KC-1135L
KC-1135R
KC-1104L
KC-1104R
KC-1145L
KC-1145R
KC-1105L
KC-1105R
KC-1106L
KC-1106R
KC-1410L
CR FEMORAL COMPONENT, SIZE 1, LEFT, POROUS COATED
KC-1410R
CR FEMORAL COMPONENT, SIZE 1, RIGHT, POROUS COATED
KC-1420L
KC-1420R
KC-1425L
CR FEMORAL COMPONENT, SIZE 2+, LEFT, POROUS COATED
KC-1425R
CR FEMORAL COMPONENT, SIZE 2+, RIGHT, POROUS COATED
KC-1430L
KC-1440L
KC-1440R
KC-1445L
KC-1445R
KC-1450L
KC-1450R
KC-1460L
KC-1460R
KC-1430R
CR FEMORAL COMPONENT, SIZE 5, RIGHT POROUS COATED
KC-1435L
KC-1435R
51
INSTRUMENT LIST
PRODUCT NUMBER
DESCRIPTION
DIAGRAM
KC-2201L
TIBIAL BASEPLATE, SIZE 1, LEFT, NON-POROUS
KC-2201R
TIBIAL BASEPLATE, SIZE 1, RIGHT, NON-POROUS
KC-2202L
KC-2202R
KC-2203L
KC-2203R
KC-2204L
KC-2204R
KC-2205L
KC-2205R
KC-2206L
KC-2206R
KC-2301L
TIBIAL BASEPLATE, SIZE 1, LEFT, POROUS, NO SCREW HOLES
KC-2301R
TIBIAL BASEPLATE, SIZE 1, RIGHT, POROUS, NO SCREW HOLES
KC-2302L
KC-2302R
KC-2303L
KC-2303R
KC-2304L
KC-2304R
KC-2305L
KC-2305R
KC-2306L
KC-2306R
KC-2401L
TIBIAL BASEPLATE, SIZE 1, LEFT, POROUS, SCREW HOLES
KC-2401R
TIBIAL BASEPLATE, SIZE 1, RIGHT, POROUS, SCREW HOLES
KC-2402L
KC-2402R
KC-2403L
KC-2403R
TIBIAL BASEPLATE, SIZE 3, RIGHT, POROUS, SCREW HOLE
KC-2404L
STIBIAL BASEPLATE, SIZE 4, LEFT, POROUS, SCREW HOLE
KC-2404R
STIBIAL BASEPLATE, SIZE 4, RIGHT, POROUS, SCREW HOLES
KC-2405L
KC-2405R
KC-2406L
KC-2406R
52
SURGICAL TECHNIQUE
PRODUCT NUMBER
DESCRIPTION
KP-20110
PS INSERT, SIZE 1 X 10MM
KP-20111
KP-20112
KP-20114
KP-20116
KP-20118
KP-20120
KP-20210
KP-20211
KP-20212
KP-20214
KP-20216
KP-20218
KP-20220
KP-20310
KP-20311
KP-20312
KP-20314
KP-20316
KP-20318
KP-20320
KP-20410
KP-20411
KP-20412
KP-20414
KP-20416
KP-20418
KP-20420
KP-20510
KP-20511
KP-20512
KP-20514
KP-20516
KP-20518
KP-20520
KP-20610
KP-20611
KP-20612
KP-20614
KP-20616
KP-20618
KP-20620
DIAGRAM
53
INSTRUMENT LIST
PRODUCT NUMBER
DESCRIPTION
KP-22110
PS-C INSERT, SIZE 1 X 10MM
KP-22111
KP-22112
KP-22114
KP-22116
KP-22118
KP-22120
KP-22210
KP-22211
KP-22212
KP-22214
KP-22216
KP-22218
KP-22220
KP-22310
KP-22311
KP-22312
KP-22314
KP-22316
KP-22318
KP-22320
KP-22410
KP-22411
KP-22412
KP-22414
KP-22416
KP-22418
KP-22420
KP-22510
KP-22511
KP-22512
KP-22514
KP-22516
KP-22518
KP-22520
KP-22610
KP-22611
KP-22612
KP-22614
KP-22616
KP-22618
KP-22620
DIAGRAM
54
SURGICAL TECHNIQUE
PRODUCT NUMBER
DESCRIPTION
DIAGRAM
KC-35010
CONGRUENT TIBIAL INSERT, SIZE 1 X 10MM
KC-35011
KC-35012
KC-35014
KC-35016
KC-35020
KC-35021
KC-35022
KC-35024
KC-35026
KC-35030
KC-35031
KC-35032
KC-35034
KC-35036
KC-35040
KC-35041
KC-35042
KC-35044
KC-35046
KC-35050
KC-35051
KC-35052
KC-35054
KC-35056
KC-35060
KC-35061
KC-35062
KC-35064
KC-35066
KC-35068
55
INSTRUMENT LIST
PRODUCT NUMBER
DESCRIPTION
KC-36010
ULTRA TIBIAL INSERT, SIZE 1 X 10MM
KC-36011
KC-36012
KC-36014
KC-36016
KC-36018
KC-36019
KC-36020
KC-36022
KC-36024
KC-36026
KC-36028
KC-36029
KC-36030
KC-36032
KC-36034
KC-36036
KC-36038
KC-36039
KC-36040
KC-36042
KC-36044
KC-36046
KC-36048
KC-36049
KC-36050
KC-36052
KC-36054
KC-36056
KC-36058
KC-36059
KC-36060
KC-36062
KC-36064
KC-36066
KC-36068
KC-36069
DIAGRAM
56
SURGICAL TECHNIQUE
PRODUCT NUMBER
DESCRIPTION
456515
15MM CANCELLOUS BONE SCREW
456520
456525
456530
456535
456540
456545
456550
DIAGRAM
KC-40268
ALL POLY PATELLA - 3 PEG, 26MM X 8MM
KC-40260
KC-40298
KC-40290
KC-40328
KC-40320
KC-40358
KC-40350
KC-40388
KC-40380
KC-40410
KS-53000
RETAINING BOLT, CONGRUENT OR ULTRA INSERT, PRIMARY TIBIAL BASEPLATE
KP-20010
RETAINING BOLT, PS OR PS‐C INSERT, PRIMARY TIBIAL BASEPLATE, 10MM
KP-20011
KP-20012
KP-20014
KP-20016
KP-20018
KP-20020
57
THE OMNIlife science
KNEE RECONSTRUCTION SYSTEMS
APEX MODULAR TIBIA™
APEX PS KNEE™
APEX CR KNEE™
Reorder No. KL-002 Rev. 11/11
Copyright 2011. OMNIlife science, Inc. All rights reserved.
OMNIlife science and APEX Knee are trademarks of OMNIlife science, Inc.
OMNIlife science™ Inc 50 O’Connell Way Suite #10 East Taunton, MA 02718
North America:
Tel 800-448-OMNI (6664) Fax 508-822-6030
International:
Tel +1 508-824-2444 Fax +1 508-822-6030
www.omnils.com

For the Surgical Technique click here

Transcription

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