(225 days)
The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis;
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of varus, valgus, or post traumatic deformity;
- Correction or revision of unsuccessful osteotomy or arthrodesis; and
- Revision procedures where other treatments or devices have failed;
OR - Treatment of fractures that are unmanageable using other techniques;
Not Found
The provided text is related to a 510(k) clearance letter for the "FS 1000 Knee System" and does not contain information about acceptance criteria or a study proving that a device meets such criteria.
The document is an FDA clearance letter from 1999, indicating that the FS 1000 Knee System is substantially equivalent to legally marketed predicate devices. It outlines the indications for use of the knee system.
Therefore, I cannot provide the requested information from the given input.
§ 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.