KYI — Prosthesis, Wrist, Carpal Trapezium Class II
FDA product code KYI covers "Prosthesis, Wrist, Carpal Trapezium", a Class II medical device regulated under 21 CFR 888.3770. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KYI
- Device Class
- Class II
- Regulation Number
- 888.3770
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201072 | ensemble orthopedics | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | December 2, 2020 |
| K180744 | skeletal dynamics | Stablyx CMC Arthroplasty Implant System | April 11, 2018 |
| K111068 | skeletal dynamics | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | December 30, 2011 |
| K112278 | ascension orthopedic | ASCENSION NUGRIP CMC IMPLANT | November 4, 2011 |
| K092548 | extremity medical | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | December 15, 2009 |
| K061956 | artimplant | ARTELON STT SPACER | June 7, 2007 |
| K061954 | artimplant | ARTELON CMC SPACER ARTHRO | June 1, 2007 |
| K061451 | ascension orthopedics | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | August 11, 2006 |
| K061089 | biopro | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 1 | June 20, 2006 |
| K060386 | nexa orthopedics | NEXA CARPO METACARPAL IMPLANT | May 10, 2006 |
| K052596 | biopro | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17 | November 15, 2005 |
| K042690 | ascension orthopedics | ASCENSION PYROSPHERE (PCS) | November 13, 2004 |
| K040070 | artimplant | ARTELON SPACER CMC-1 | September 21, 2004 |
| K041451 | ascension orthopedics | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, | August 25, 2004 |
| K033529 | wrightmedicaltechnologyinc | TIE-IN TRAPEZIUM | December 3, 2003 |
| K965204 | avanta orthopaedics | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | June 3, 1997 |
| K960659 | wrightmedicaltechnologyinc | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) | February 6, 1997 |
| K960534 | wrightmedicaltechnologyinc | METALLIC SPHERICAL CMC IMPLANT | February 6, 1997 |
| K964472 | biologically oriented prostheses | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | February 3, 1997 |
| K964381 | avanta orthopaedics | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | January 22, 1997 |