JWJ · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Orthopedic · 21 CFR 888.3800 · Class 2
Overview
| Product Code | JWJ |
|---|---|
| Device Name | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Regulation | 21 CFR 888.3800 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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).
Classification Rationale
Class II.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243381 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | Nov 1, 2024 | SESE |
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | Jul 3, 2024 | SESE |
| K233674 | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | May 30, 2024 | SESE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | Oct 15, 2020 | SESE |
| K191525 | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | Mar 4, 2020 | SESE |
| K132250 | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | Integra LifeSciences Corporation | Mar 24, 2014 | SESE |
| K080426 | MAESTRO WRIST FRACTURE IMPLANT | Biomet Manufacturing Corp | Jul 29, 2008 | SESE |
| K042032 | MAESTRO TOTAL WRIST | Biomet, Inc. | Oct 7, 2004 | SESE |
| K031203 | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | DePuy Orthopaedics, Inc. | Jul 14, 2003 | SESE |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | Feb 5, 2003 | SESE |
| K021859 | WRIST IMPLANT | Avanta Orthopaedics, Inc. | Dec 2, 2002 | SESE |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | May 3, 2002 | SESE |
| K982156 | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | Pasco Laboratories, Inc. | Jul 29, 1998 | SESE |
| K961051 | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | Kinetikos Medical, Inc. | Jun 6, 1996 | SESE |
| K931131 | THE RICHARDS WRIST | Smith & Nephew Richards, Inc. | Aug 19, 1994 | SN |
| K802032 | MINI MICK APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Oct 23, 1980 | SESE |
| K792650 | HAMAS PRECENTERED TOTAL WRIST | Zimmer, Inc. | Jan 28, 1980 | SESE |
Top Applicants
- Kinetikos Medical, Inc. — 3 clearances
- Arthrosurface, Inc. — 1 clearance
- Ascension Orthopedics, Inc. — 1 clearance
- Avanta Orthopaedics, Inc. — 1 clearance
- Biomet Manufacturing Corp — 1 clearance
