KYI · Prosthesis, Wrist, Carpal Trapezium
Orthopedic · 21 CFR 888.3770 · Class 2
Overview
| Product Code | KYI |
|---|---|
| Device Name | Prosthesis, Wrist, Carpal Trapezium |
| Regulation | 21 CFR 888.3770 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | Dec 2, 2020 | SESE |
| K180744 | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC | Apr 11, 2018 | SESE |
| K111068 | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | Skeletal Dynamics, LLC | Dec 30, 2011 | SESE |
| K112278 | ASCENSION NUGRIP CMC IMPLANT | Ascension Orthopedic | Nov 4, 2011 | SESE |
| K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | Extremity Medical, LLC | Dec 15, 2009 | SESE |
| K061956 | ARTELON STT SPACER | Artimplant AB | Jun 7, 2007 | SESE |
| K061954 | ARTELON CMC SPACER ARTHRO | Artimplant AB | Jun 1, 2007 | SESE |
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | Aug 11, 2006 | SESE |
| K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | Biopro, Inc. | Jun 20, 2006 | SESE |
| K060386 | NEXA CARPO METACARPAL IMPLANT | Nexa Orthopedics, Inc. | May 10, 2006 | SESE |
| K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | Biopro, Inc. | Nov 15, 2005 | SESE |
| K042690 | ASCENSION PYROSPHERE (PCS) | Ascension Orthopedics, Inc. | Nov 13, 2004 | SESE |
| K040070 | ARTELON SPACER CMC-1 | Artimplant AB | Sep 21, 2004 | SESE |
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 | Ascension Orthopedics, Inc. | Aug 25, 2004 | SESE |
| K033529 | TIE-IN TRAPEZIUM | Wrightmedicaltechnologyinc | Dec 3, 2003 | SESE |
| K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | Avanta Orthopaedics, Inc. | Jun 3, 1997 | SN |
| K960659 | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) | Wrightmedicaltechnologyinc | Feb 6, 1997 | SESE |
| K960534 | METALLIC SPHERICAL CMC IMPLANT | Wrightmedicaltechnologyinc | Feb 6, 1997 | SESE |
| K964472 | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | Biologically Oriented Prostheses | Feb 3, 1997 | SESE |
| K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | Avanta Orthopaedics, Inc. | Jan 22, 1997 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 4 clearances
- Artimplant AB — 3 clearances
- Ascension Orthopedics, Inc. — 3 clearances
- Avanta Orthopaedics, Inc. — 2 clearances
- Biopro, Inc. — 2 clearances
