Data / Medical devices / Prosthesis, Ankle, Uncemented, Non-Constrained

Prosthesis, Ankle, Uncemented, Non-Constrained (NTG): 17 FDA-registered makers in 4 countries

Name: FDA-registered makers of Prosthesis, Ankle, Uncemented, Non-Constrained
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 4 countries are registered with the FDA to make Prosthesis, Ankle, Uncemented, Non-Constrained (product code NTG, Class 3). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: NTG
Device class: 3
Medical specialty: Unknown
Implant: Yes
Life sustaining or supporting: Yes

Makers by country

Country	Makers
United States	14
Italy	1
France	1
Switzerland	1

Makers of Prosthesis, Ankle, Uncemented, Non-Constrained

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	PMA approvals	Recall events	Source
DT Medtech LLC	McMinnville, TN, United States	Specification developer	1	2	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Complaint file establishment, Specification developer	1	0	api.fda.gov
Arthrosurface, Inc.	W Bridgewater, MA, United States	Manufacturer for export	0	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0	0	api.fda.gov
Avalign Instruments & Implants	Fort Wayne, IN, United States	Contract manufacturer	0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer for export	0	1	api.fda.gov
Isomedix Operations Inc.	Northborough, MA, United States	Manufacturer for export	0	0	api.fda.gov
Isomedix Operations, Inc.	Libertyville, IL, United States	Contract sterilizer, Manufacturer for export	0	0	api.fda.gov
Lincotek Trento S.P.A	Cire di Pergine Trento, Italy	Contract manufacturer	0	0	api.fda.gov
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	Contract manufacturer	0	0	api.fda.gov
Medin Technologies, Inc.	Totowa, NJ, 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
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0	0	api.fda.gov
Simagec	ROUSSET CEDEX Bouches-du-Rhone, France	Contract manufacturer	0	0	api.fda.gov
STRYKER GmbH	SELZACH Solothurn, Switzerland	Contract manufacturer	0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer for export	0	0	api.fda.gov

Updated November 2, 2026. 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.