(71 days)
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or The only ar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different companents of the Stryker Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:
- Degenerative arthritis in the distal femur and patella, .
- Patients with a history of patellar dislocation or patella fracture, .
- Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where ● pain, deformity or dysfunction persists,
- Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic . arthritis,
- Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous . use of an unicompartmental knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated . by deficiencies of the femoral condyle/tibial plateau.
These components are single use only and are intended for implantation with bone cement.
The Stryker® Compartmental Knee System consists of sterile, single-use components intended for r ne our new - Companiside of the patellofemoral joint and/or the condyle region(s) of the femoral rophoominent of the system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Osteonics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.
This 510(k) summary describes a new medical device, the Stryker® Compartmental Knee System, and demonstrates its substantial equivalence to previously marketed devices. However, it does not contain information regarding pre-established acceptance criteria for device performance or a study demonstrating the device meets such criteria.
The document focuses on:
- Device Identification and Description: Detailing the components and intended use of the Stryker® Compartmental Knee System (sterile, single-use components for knee arthroplasty).
- Indications for Use: Listing the specific conditions for which the device is intended (e.g., degenerative arthritis, failed previous surgeries).
- Substantial Equivalence: Asserting that the device is substantially equivalent to existing predicate devices based on indications for use, materials, and operational principles. The document explicitly states: "The analyses armonstrate that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement."
- FDA Clearance Letter: Confirming that the FDA has reviewed the 510(k) premarket notification and found the device substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study proving the device meets those criteria because this information is not present in the provided text.
The document is a regulatory submission for premarket clearance based on substantial equivalence to existing devices, not a performance study against specific acceptance criteria. This type of submission relies on the safety and effectiveness of the predicate devices.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.