(64 days)
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- Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic).
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- Revision of a failed unicompartmental knee implant or other procedure.
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- Alternative to tibial osteotomy in patients with unicompartmental arthritis.
StelKast Unicondylar Knee System
I'm sorry, but this document does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device (StelKast Unicondylar Knee System), which indicates that the device is substantially equivalent to a legally marketed predicate device.
The clearance letter does not include:
- Acceptance criteria for device performance.
- Any study details for evaluating the device's performance against acceptance criteria (e.g., sample size, data provenance, expert involvement, ground truth methods, MRMC studies, or standalone algorithm performance).
The information provided pertains to regulatory clearance, not performance study outcomes.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.