Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3800](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3800) → JWJ — Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained # JWJ · Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained _Orthopedic · 21 CFR 888.3800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ ## Overview - **Product Code:** JWJ - **Device Name:** Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained - **Regulation:** [21 CFR 888.3800](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3800) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K243381.md) | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics, Inc. | Nov 1, 2024 | SESE | | [K233574](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K233574.md) | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | Jul 3, 2024 | SESE | | [K233674](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K233674.md) | Freedom Wrist Arthroplasty System | Ascension Orthopedics, Inc. | May 30, 2024 | SESE | | [K200718](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K200718.md) | Arthrosurface WristMotion Total Wrist Arthroplasty System | Arthrosurface, Inc. | Oct 15, 2020 | SESE | | [K191525](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K191525.md) | KinematX Total Wrist Arthroplasty System | Extremity Medical, LLC | Mar 4, 2020 | SESE | | [K132250](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K132250.md) | INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM | Integra LifeSciences Corporation | Mar 24, 2014 | SESE | | [K080426](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K080426.md) | MAESTRO WRIST FRACTURE IMPLANT | Biomet Manufacturing Corp | Jul 29, 2008 | SESE | | [K042032](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K042032.md) | MAESTRO TOTAL WRIST | Biomet, Inc. | Oct 7, 2004 | SESE | | [K031203](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K031203.md) | BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST | DePuy Orthopaedics, Inc. | Jul 14, 2003 | SESE | | [K030037](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K030037.md) | UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | Feb 5, 2003 | SESE | | [K021859](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K021859.md) | WRIST IMPLANT | Avanta Orthopaedics, Inc. | Dec 2, 2002 | SESE | | [K020554](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K020554.md) | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | Kinetikos Medical, Inc. | May 3, 2002 | SESE | | [K982156](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K982156.md) | PASCO MIC AND MIC/ID PANELS/ CEFDINIR | Pasco Laboratories, Inc. | Jul 29, 1998 | SESE | | [K961051](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K961051.md) | UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) | Kinetikos Medical, Inc. | Jun 6, 1996 | SESE | | [K931131](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K931131.md) | THE RICHARDS WRIST | Smith & Nephew Richards, Inc. | Aug 19, 1994 | SN | | [K802032](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K802032.md) | MINI MICK APPLICATOR | Mick Radio-Nuclear Instruments, Inc. | Oct 23, 1980 | SESE | | [K792650](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ/K792650.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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