FDA 510(k) Applications for Medical Device Product Code "KYI"
(Prosthesis, Wrist, Carpal Trapezium)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K061954 | ARTIMPLANT AB | ARTELON CMC SPACER ARTHRO | 06/01/2007 |
| K040070 | ARTIMPLANT AB | ARTELON SPACER CMC-1 | 09/21/2004 |
| K061956 | ARTIMPLANT AB | ARTELON STT SPACER | 06/07/2007 |
| K112278 | ASCENSION ORTHOPEDIC | ASCENSION NUGRIP CMC IMPLANT | 11/04/2011 |
| K041451 | ASCENSION ORTHOPEDICS, INC. | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 | 08/25/2004 |
| K042690 | ASCENSION ORTHOPEDICS, INC. | ASCENSION PYROSPHERE (PCS) | 11/13/2004 |
| K061451 | ASCENSION ORTHOPEDICS, INC. | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | 08/11/2006 |
| K964381 | AVANTA ORTHOPAEDICS, INC. | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | 01/22/1997 |
| K965204 | AVANTA ORTHOPAEDICS, INC. | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | 06/03/1997 |
| K964472 | BIOLOGICALLY ORIENTED PROSTHESES | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | 02/03/1997 |
| K052596 | BIOPRO, INC. | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507 | 11/15/2005 |
| K061089 | BIOPRO, INC. | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | 06/20/2006 |
| K201072 | Ensemble Orthopedics, LLC | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | 12/02/2020 |
| K092548 | EXTREMITY MEDICAL LLC | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | 12/15/2009 |
| K060386 | NEXA ORTHOPEDICS, INC. | NEXA CARPO METACARPAL IMPLANT | 05/10/2006 |
| K111068 | SKELETAL DYNAMICS, LLC | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | 12/30/2011 |
| K180744 | Skeletal Dynamics, LLC | Stablyx CMC Arthroplasty Implant System | 04/11/2018 |
| K960659 | WRIGHT MEDICAL TECHNOLOGY, INC. | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) | 02/06/1997 |
| K960534 | WRIGHT MEDICAL TECHNOLOGY, INC. | METALLIC SPHERICAL CMC IMPLANT | 02/06/1997 |
| K033529 | WRIGHT MEDICAL TECHNOLOGY, INC. | TIE-IN TRAPEZIUM | 12/03/2003 |
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