(268 days)
The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:
- Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
- Revision where other devices or treatments have failed
- Scapholunate Advanced Collapse (SLAC)
- Rheumatoid Arthritis
The device is intended to be implanted with bone cement.
The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:
- Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
- Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.
This FDA document, K191525, describes the KinematX Total Wrist Arthroplasty System. However, it does not include details about acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies. It explicitly states that "No clinical testing was performed."
Therefore, I cannot provide the requested information based on the provided text. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing (mechanical and cadaveric evaluations) and a comparison of indications for use, materials, and design.
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist 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 either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.