(223 days)
The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:
- Replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and
- Failed ulnar head resection.
It is intended for patient matched use with bone cement and or press-fit fixation.
The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Kapp Patient Matched Ulnar Head Wrist Implant) and details its identification, description, and indications for use, but does not include performance data, study designs, or acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.