Panels › Orthopedic › Product code KYI · Class 2
Prosthesis, Wrist, Carpal Trapezium
Regulation 888.3770
0510(k)s in 12 months (26 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in KYI
| Company | 510(k)s | Recalls |
|---|---|---|
| Ascension Orthopedics, Inc. | 3 | 2 |
| Wrightmedicaltechnologyinc | 4 | 0 |
| Artimplant AB | 3 | 0 |
| Avanta Orthopaedics, Inc. | 2 | 1 |
| Biopro, Inc. | 2 | 0 |
| Dow Corning Wright | 2 | 0 |
| Skeletal Dynamics, LLC | 2 | 0 |
| Ascension Orthopedic | 1 | 0 |
| B.H. Richardson, D.C. | 1 | 0 |
| Biologically Oriented Prostheses | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2020 | K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 Ensemble Orthopedics, LLC | KYI |
| Apr 11, 2018 | K180744 | Stablyx CMC Arthroplasty Implant System Skeletal Dynamics, LLC | KYI |
| Dec 30, 2011 | K111068 | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 Skeletal Dynamics, LLC | KYI |
| Nov 4, 2011 | K112278 | ASCENSION NUGRIP CMC IMPLANT Ascension Orthopedic | KYI |
| Dec 15, 2009 | K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS Extremity Medical, LLC | KYI |
| Jun 7, 2007 | K061956 | ARTELON STT SPACER Artimplant AB | KYI |
| Jun 1, 2007 | K061954 | ARTELON CMC SPACER ARTHRO Artimplant AB | KYI |
| Aug 11, 2006 | K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 Ascension Orthopedics, Inc. | KYI |
| Jun 20, 2006 | K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 Biopro, Inc. | KYI |
| May 10, 2006 | K060386 | NEXA CARPO METACARPAL IMPLANT Nexa Orthopedics, Inc. | KYI |
| Nov 15, 2005 | K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 Biopro, Inc. | KYI |
| Nov 13, 2004 | K042690 | ASCENSION PYROSPHERE (PCS) Ascension Orthopedics, Inc. | KYI |
| Sep 21, 2004 | K040070 | ARTELON SPACER CMC-1 Artimplant AB | KYI |
| Aug 25, 2004 | K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 Ascension Orthopedics, Inc. | KYI |
| Dec 3, 2003 | K033529 | TIE-IN TRAPEZIUM Wrightmedicaltechnologyinc | KYI |
| Jun 3, 1997 | K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT Avanta Orthopaedics, Inc. | KYI |
| Feb 6, 1997 | K960659 | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) Wrightmedicaltechnologyinc | KYI |
| Feb 6, 1997 | K960534 | METALLIC SPHERICAL CMC IMPLANT Wrightmedicaltechnologyinc | KYI |
| Feb 3, 1997 | K964472 | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT Biologically Oriented Prostheses | KYI |
| Jan 22, 1997 | K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT Avanta Orthopaedics, Inc. | KYI |
| Aug 9, 1995 | K951471 | STRICKLAND TRAPEZIAL IMPLANT Wrightmedicaltechnologyinc | KYI |
| Apr 15, 1987 | K864489 | SWANSON TITANIUM TRAPEZIUM IMPLANT Dow Corning Wright | KYI |
| Apr 15, 1987 | K864488 | SWANSON TITANIUM CONDYLAR IMPLANT Dow Corning Wright | KYI |
| Sep 16, 1980 | K801952 | SPINE ALIGN B.H. Richardson, D.C. | KYI |
| Apr 10, 1979 | K790508 | TRAPEZIO-METACARPAL JOINT SPACER Scientific Data Systems Israel, Ltd. | KYI |
| Nov 15, 1978 | K781756 | SILASTIC H.P. TRAPEXIAL IMPLANT Dow Corning Corp. Healthcare Industries Materials | KYI |
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