Data / Medical devices / Prosthesis, Wrist, Carpal Trapezium

Prosthesis, Wrist, Carpal Trapezium (KYI): 17 FDA-registered makers in 2 countries

Name: FDA-registered makers of Prosthesis, Wrist, Carpal Trapezium
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 2 countries are registered with the FDA to make Prosthesis, Wrist, Carpal Trapezium (product code KYI, Class 2, 21 CFR 888.3770). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 26 510(k) clearances under this code, the latest on December 2, 2020, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: KYI
Device class: 2
Regulation: 888.3770
Medical specialty: Orthopedic
Implant: Yes

Makers by country

Country	Makers
United States	15
France	2

Makers of Prosthesis, Wrist, Carpal Trapezium

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Biopro, Inc.	Port Huron, MI, United States	Manufacturer	3	June 20, 2006	0	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	3	December 3, 2003	1	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	3	December 3, 2003	0	api.fda.gov
Skeletal Dynamics, Inc	Miami, FL, United States	Complaint file establishment, Repackager or relabeler, Specification developer	2	April 11, 2018	0	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer, Manufacturer for export	2	November 4, 2011	0	api.fda.gov
Ensemble Orthopedics, Inc	Austin, TX, United States	Manufacturer	1	December 2, 2020	0	api.fda.gov
TORNIER Inc.	Columbia City, IN, United States	Specification developer	1	May 10, 2006	0	api.fda.gov
Tornier S.A.S.	Montbonnot Saint-Martin Isere, France	Exporter to the US, Manufacturer	1	May 10, 2006	0	api.fda.gov
Banister Tool, Inc.	Pflugerville, TX, United States	Contract manufacturer	0		0	api.fda.gov
Medical Device And Implants LLC	Lancaster, PA, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC.	Fall River, MA, United States	Contract manufacturer	0		0	api.fda.gov
On-X Life Technologies Inc.	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Naples, FL, United States	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Tornier, SAS	GRENOBLE CEDEX 1 Isere, France	Contract manufacturer	0		0	api.fda.gov

Updated December 2, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.