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.
Cleared Devices (26)
| 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 |
| K951471 | STRICKLAND TRAPEZIAL IMPLANT | Wrightmedicaltechnologyinc | Aug 9, 1995 | SESE |
| K864489 | SWANSON TITANIUM TRAPEZIUM IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |
| K864488 | SWANSON TITANIUM CONDYLAR IMPLANT | Dow Corning Wright | Apr 15, 1987 | SESE |
| K801952 | SPINE ALIGN | B.H. Richardson, D.C. | Sep 16, 1980 | SESE |
| K790508 | TRAPEZIO-METACARPAL JOINT SPACER | Scientific Data Systems Israel, Ltd. | Apr 10, 1979 | SESE |
| K781756 | SILASTIC H.P. TRAPEXIAL IMPLANT | Dow Corning Corp. Healthcare Industries Materials | Nov 15, 1978 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 4 clearances
- Ascension Orthopedics, Inc. — 3 clearances
- Artimplant AB — 3 clearances
- Skeletal Dynamics, LLC — 2 clearances
- Dow Corning Wright — 2 clearances
