(112 days)
- Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
- Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
- For cemented use only.
Stelkast Proven Cemented, Semi-Constrained Total Knee System
This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically a total knee system. It states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is a regulatory approval notice based on substantial equivalence, which is a different regulatory pathway than requiring clinical studies to prove specific performance metrics.
Therefore, I cannot provide the requested information from this document.
§ 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.