Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3770](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3770) → KYI — Prosthesis, Wrist, Carpal Trapezium # KYI · Prosthesis, Wrist, Carpal Trapezium _Orthopedic · 21 CFR 888.3770 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI ## Overview - **Product Code:** KYI - **Device Name:** Prosthesis, Wrist, Carpal Trapezium - **Regulation:** [21 CFR 888.3770](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3770) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K201072.md) | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | Ensemble Orthopedics, LLC | Dec 2, 2020 | SESE | | [K180744](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K180744.md) | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC | Apr 11, 2018 | SESE | | [K111068](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K111068.md) | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 | Skeletal Dynamics, LLC | Dec 30, 2011 | SESE | | [K112278](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K112278.md) | ASCENSION NUGRIP CMC IMPLANT | Ascension Orthopedic | Nov 4, 2011 | SESE | | [K092548](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K092548.md) | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | Extremity Medical, LLC | Dec 15, 2009 | SESE | | [K061956](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K061956.md) | ARTELON STT SPACER | Artimplant AB | Jun 7, 2007 | SESE | | [K061954](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K061954.md) | ARTELON CMC SPACER ARTHRO | Artimplant AB | Jun 1, 2007 | SESE | | [K061451](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K061451.md) | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 | Ascension Orthopedics, Inc. | Aug 11, 2006 | SESE | | [K061089](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K061089.md) | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | Biopro, Inc. | Jun 20, 2006 | SESE | | [K060386](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K060386.md) | NEXA CARPO METACARPAL IMPLANT | Nexa Orthopedics, Inc. | May 10, 2006 | SESE | | [K052596](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K052596.md) | 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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K042690.md) | ASCENSION PYROSPHERE (PCS) | Ascension Orthopedics, Inc. | Nov 13, 2004 | SESE | | [K040070](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K040070.md) | ARTELON SPACER CMC-1 | Artimplant AB | Sep 21, 2004 | SESE | | [K041451](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K041451.md) | 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](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K033529.md) | TIE-IN TRAPEZIUM | Wrightmedicaltechnologyinc | Dec 3, 2003 | SESE | | [K965204](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K965204.md) | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | Avanta Orthopaedics, Inc. | Jun 3, 1997 | SN | | [K960659](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K960659.md) | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) | Wrightmedicaltechnologyinc | Feb 6, 1997 | SESE | | [K960534](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K960534.md) | METALLIC SPHERICAL CMC IMPLANT | Wrightmedicaltechnologyinc | Feb 6, 1997 | SESE | | [K964472](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K964472.md) | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | Biologically Oriented Prostheses | Feb 3, 1997 | SESE | | [K964381](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI/K964381.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KYI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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