Ensemble CMC Trial, Size 141

• FDA 510(k) K201072 decided 2 Dec 2020 Active
• FDA GUDID UDI-DI 00810063560058 listed 30 Mar 2021 Listed

1. 2 Dec 2020 Cleared FDA 510(k) K201072
2. 30 Mar 2021 Listed FDA GUDID 00810063560058

Trade name

Ensemble CMC

Generic name

Metacarpal prosthesis

Model / Ref / Catalog

Ensemble CMC Trial, Size 141, 103-TRL-141

Primary DI / UDI-DI

00810063560058

510(k) Number

K201072 ↗

FDA product code

KYI

GMDN term

Metacarpal prosthesis

Device class

Class II

Regulation number

888.3770

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Metacarpal prosthesis

Other devices filed under FDA product code KYI (Prosthesis, Wrist, Carpal Trapezium).

• ASCENSION, MODELS CMC-400, 13, CMC-400-20, CMC-400-30, CMC-400-40 by Ascension Orthopedics, Inc.
• ASCENSION PYROSPHERE (PCS) by Ascension Orthopedics, Inc.
• STABLYX CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 by SKELETAL DYNAMICS, INC
• Silastic H.P. Trapexial Implant by Dow Corning Corp. Healthcare Industries Materials
• Tie-In Trapezium by Wrightmedicaltechnologyinc
• MODULAR THUMB IMPLANT, MODELS 17065, 17066, 17243, 17067, 17199, 17238, 17005, 17239, 17006, 17240, 17007, 17241, 17500, 17501, 17507 by BIOPRO, INC.
• ARTELON CMC SPACER ARTHRO by Artimplant AB
• EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS by Extremity Medical, LLC
• SWANSON TITANIUM TRAPEZIUM IMPLANT by Dow Corning Wright
• TRAPEZIO-METACARPAL JOINT SPACER by Scientific Data Systems Israel, Ltd.

• Ensemble CMC Ensemble Instrument Tray

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

• Ensemble CMC Implant, Size 161

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

• Ensemble CMC Implant, Size 141

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

• Ensemble CMC Implant Holder

  Class II

  FDA 510(k) K201072 Active Cleared 2 Dec 2020 GUDID on market

See all devices from Ensemble Orthopedics, LLC →