Unicondylar Knee System

Unicondylar Knee System
Surgical Protocol and Product Specifications
Unicondylar Knee System
Minimally Invasive Medial Approach
Fig. 1
Provide exposure of the medial compartment of the
effected knee. Utilize the appropriate sizing template
(Fig. 1) to determine the femur size and mark the
posterior resection with an electrocautery. Resect the
posterior femoral condyle approximately 5-8mm.
Tibial Preparation
Fig. 2
Insert the retractor pins by pre-drilling with a 4.5mm drill
or similar sized (3/16”) Steinmen pin. One pin is placed
straight in the middle of the medial condyle and the
other is placed at 45 degrees medially on the proximal
tibia. With the pins in place, utilize the distractor for
exposure (Fig. 2) along with a Gelpi retractor Chandler
shoulder elevator.
Remove the meniscus with electrocautery and clear the
tibial articular cartilage with a curette to ease the burring
process. A sizing template (Fig. 3) can be used to mark the
size of the tibial insert.
Use a 5mm bur to prepare the tibia for the inlay component.
The preparation should be approximately 2-3mm anteriorly
and 5mm posteriorly to allow appropriate flexion. Caution
should be used to ensure adequate sclerotic bone and
peripheral rim of bone is maintained.
An Osteotome or straight drill can be used to clear the
corners of the bur cuts. A tibial gauge (Fig. 4) or trial
insert (Fig. 5) can be used to check the tibial preparation.
Fig. 3
Fig. 4
Fig. 5
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Femoral Preparation
Fig. 6
The articular cartilage should be removed from the distal
femur with the use of a saw or bur (Fig. 6).
The femoral guide (Fig. 7) is impacted into position on the
femur to ensure adequate contact. Pins can be positioned on
the guide to hold it in place on the femur.
The center hole stop drill can be inserted into the guide
handle (Fig. 8) to prepare the femur for the implant.
After removing the handle, a saw can be passed through the
guide (Fig. 9) to cut the femoral keel.
Fig. 7
Fig. 8
Fig. 9
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Unicondylar Knee System
Trial Reduction
The femur trial can be impacted on the femur and the tibial
trial set into the tibial preparation to perform a trial reduction
(Fig. 10). The trial reduction should assess the stability of
the implant through range of motion.
Fig. 10
Cementation
It is helpful to apply cement to the tibial insert and a thin
layer of cement in the tibial pocket. The tibial component
should be cemented and excess cement removed. The tibial
inserter (Fig. 11) can be utilized to assist in the placement of
the insert and compression of the cement.
The femur can be cemented in place with the assistance of
the femoral impactor (Fig. 12) and excess cement removed.
Fig. 11
Fig. 12
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GENERAL PRODUCT INFORMATION
The Unicondylar Knee System consists of femoral components and tibial components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial components are ultra high
molecular weight polyethylene conforming to ASTM F-648.
CAUTION: For Cemented Use Only.
PACKAGING
The femoral components are supplied in a double Tyvek package. The tibial components are packaged in an inner foil pouch and placed in an outer Tyvek
package. If the seal or package is breached, then the component should not be used.
CAUTION
Federal law restricts this device to sale by or on the order of a physician.
INDICATIONS FOR USE
The Unicondylar Knee System is indicated for use in individuals undergoing surgery for 1) unicompartmental knee replacement due to moderately disabling
joint disease of the knee resulting from painful osteo- or post-traumatic arthritis 2) revision of previous unsuccessful unicompartmental knee replacement or
other procedure 3) as an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
CONTRAINDICATIONS
The Unicondylar Knee System is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and
fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular
disorders that do not allow control of the knee joint, and in patients whose weight, age or activity level might cause extreme loads and early failure of the
system.
WARNINGS & PRECAUTIONS
Familiarity with and attention to appropriate surgical technique for unicompartmental arthroplasty and the Unicondylar Knee System is essential for success
of the procedure.
Care should be utilized in the handling of the components to minimize contamination of the component surfaces. In using cement for fixation, the surgeon
should use care to insure complete cement support on all parts of the prosthesis embedded in bone cement.
Only surgeons who have reviewed the literature regarding unicompartmental knee surgery and have had training in the technique should utilize the device.
The surgeon or his designee should instruct patients in the limitations of the prosthesis, and these patients should be taught to govern their activities accordingly.
Implants must not be reused. The surgeon must not allow damage to polished bearing surfaces because this may accelerate wear of the components. Any
alteration or damage to a component may result in failure under load. Any prostheses so damaged must not be used. Components of the Stelkast Unicondylar Knee System should not be used with those of another manufacturer since articular and dimensional compatibility cannot be assured.
Unicondylar Knee implant components have not been evaluated for safety and compatibility in the MR environment. Unicondylar Knee implant components
have not been tested for heating or migration in the MR environment.
ADVERSE EFFECTS
As with any knee system, potential adverse effects include infection, loosening of the components, breakage or bending of the components, or change in
position of the components. There have been reports of sensitivity reactions to the components of knee replacement systems. Other potential adverse effects of knee surgery include neurovascular damage, dislocation, thromboembolic disease, and other less common adverse effect s.
STERILIZATION
A minimum of 2.5 megarads of gamma irradiation is utilized for femoral and tibial components. The tibial components are subjected to gamma sterilization
in inert gas. Do not use any component if the package has been breached. The components are not represented to be "pyrogen free".
UTILIZATION AND IMPLANTATION
Selection of the Unicondylar Knee System depends on the judgment of the surgeon with regard to the relationship to the requirements of the patient. The
surgeon should become thoroughly familiar with the technique of implantation of the prostheses by 1) appropriate reading of the literature, and 2) training
in the operative skills and techniques required for unicompartmental arthroplasty surgery.
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Unicondylar Knee System
Product Specifications
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

Anatomic Femoral Component – 5 sizes
Inlay Tibial Component – 9 sizes
Small Incision Instrumentation
Tibial Inlay
Tibial Inlay Special Order
Item
Description
Item
Description
SC3405-1-6
INLAY TIBIAL COMPONENT, SIZE 1 X 6.5 MM
SC3405-3X-6
INLAY TIBIAL COMPONENT, SIZE 3 X 6.5 MM
SC3405-1-7
INLAY TIBIAL COMPONENT, SIZE 1 X 7.5 MM
SC3405-3X-7
INLAY TIBIAL COMPONENT, SIZE 3 X 7.5 MM
SC3405-1-8
INLAY TIBIAL COMPONENT, SIZE 1 X 8.5 MM
SC3405-3X-8
INLAY TIBIAL COMPONENT, SIZE 3 X 8.5 MM
SC3405-2-6
INLAY TIBIAL COMPONENT, SIZE 2 X 6.5 MM
SC3405-4X-6
INLAY TIBIAL COMPONENT, SIZE 4 X 6.5 MM
SC3405-2-7
INLAY TIBIAL COMPONENT, SIZE 2 X 7.5 MM
SC3405-4X-7
INLAY TIBIAL COMPONENT, SIZE 4 X 7.5 MM
SC3405-2-8
INLAY TIBIAL COMPONENT, SIZE 2 X 8.5 MM
SC3405-4X-8
INLAY TIBIAL COMPONENT, SIZE 4 X 8.5 MM
SC3405-3-6
INLAY TIBIAL COMPONENT, SIZE 3 X 6.5 MM
SC3405-5X-6
INLAY TIBIAL COMPONENT, SIZE 5 X 6.5 MM
SC3405-3-7
INLAY TIBIAL COMPONENT, SIZE 3 X 7.5 MM
SC3405-5X-7
INLAY TIBIAL COMPONENT, SIZE 5 X 7.5 MM
SC3405-3-8
INLAY TIBIAL COMPONENT, SIZE 3 X 8.5 MM
SC3405-5X-8
INLAY TIBIAL COMPONENT, SIZE 5 X 8.5 MM
SC3405-4-6
INLAY TIBIAL COMPONENT, SIZE 4 X 6.5 MM
SC3405-6X-6
INLAY TIBIAL COMPONENT, SIZE 6 X 6.5 MM
SC3405-4-7
INLAY TIBIAL COMPONENT, SIZE 4 X 7.5 MM
SC3405-6X-7
INLAY TIBIAL COMPONENT, SIZE 6 X 7.5 MM
SC3405-4-8
INLAY TIBIAL COMPONENT, SIZE 4 X 8.5 MM
SC3405-6X-8
INLAY TIBIAL COMPONENT, SIZE 6 X 8.5 MM
SC3405-5-6
INLAY TIBIAL COMPONENT, SIZE 5 X 6.5 MM
SC3405-5-7
INLAY TIBIAL COMPONENT, SIZE 5 X 7.5 MM
SC3405-5-8
INLAY TIBIAL COMPONENT, SIZE 5 X 8.5 MM
Note: SC3405 replaces SC2380
Femoral Component
Item
Description
SC2461-1
FEMORAL COMPONENT, LM/RL, SIZE 1
SC2461-2
FEMORAL COMPONENT, LM/RL, SIZE 2
SC2461-3
FEMORAL COMPONENT, LM/RL, SIZE 3
SC2461-4
FEMORAL COMPONENT, LM/RL, SIZE 4
SC2461-5
FEMORAL COMPONENT, LM/RL, SIZE 5
SC2462-1
FEMORAL COMPONENT, RM/LL SIZE 1
SC2462-2
FEMORAL COMPONENT, RM/LL SIZE 2
SC2462-3
FEMORAL COMPONENT, RM/LL SIZE 3
SC2462-4
FEMORAL COMPONENT, RM/LL SIZE 4
SC2462-5
FEMORAL COMPONENT, RM/LL SIZE 5
www.stelkast.com
FM-692 Rev. B
200 Hidden Valley Road | McMurray, PA 15317
phone: (724) 941-6368 | fax: (724) 941-5987 | www.stelKast.com
Last revised 06-07-11