Data / Medical devices / Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer / United States

FDA-registered makers of Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer in the United States: 61 establishments

Name: FDA-registered makers of Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

61 establishments in the United States are registered with the FDA to make Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer (product code HSN). 12 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Product code: HSN
Country: United States

Makers of Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Wright Medical Technology, Inc.	Arlington, TN, United States	Manufacturer	24	June 16, 2026	3	api.fda.gov
Wright Medical Technology, Inc.	Arlington, TN, United States	Complaint file establishment, Specification developer	24	June 16, 2026	4	api.fda.gov
Smith & Nephew, Inc.	Memphis, TN, United States	Manufacturer	7	June 29, 2020	0	api.fda.gov
Paragon 28	Englewood, CO, United States	Complaint file establishment, Manufacturer, Specification developer	6	October 7, 2026	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	4	October 31, 2012	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	4	October 12, 2023	4	api.fda.gov
restor3d, inc.	Durham, NC, United States	Complaint file establishment, Manufacturer	4	October 18, 2024	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	3	October 31, 2012	0	api.fda.gov
Vilex LLC	Mcminnville, TN, United States	Manufacturer	3	December 2, 2024	0	api.fda.gov
Exactech Sarasota	Sarasota, FL, United States	Manufacturer	1	March 10, 2016	0	api.fda.gov
Triangle Machine, Inc.	South Bend, IN, United States	Manufacturer	1	August 24, 2012	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Manufacturer	1	August 24, 2012	2	api.fda.gov
Alva Prototypes Inc	Pottstown, PA, United States	Contract manufacturer	0		0	api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical Components	Huntingdon Valley, PA, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Elmhurst	Elmhurst, IL, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Warsaw	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Kentwood, MI, United States	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Plymouth, MA, United States	Contract manufacturer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, 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
Bioseal	Placentia, CA, United States	Contract manufacturer	0		0	api.fda.gov
C&W Swiss, Inc.	Clayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Cep Bio-Coat, LLC	Farmington Hills, MI, United States	Contract manufacturer	0		0	api.fda.gov
Complexus Medical	Mishawaka, IN, United States	Contract manufacturer	0		0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	api.fda.gov
Eptam Plastics, Ltd	Northfield, NH, United States	Contract manufacturer	0		0	api.fda.gov
Engineered Medical Systems, LLC	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Five Star Manufacturing, Inc.	New Bedford, MA, United States	Contract manufacturer	0		0	api.fda.gov
Haven Manufacturing	Ossian, IN, United States	Contract manufacturer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical, LLC	Molalla, OR, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical LLC	Vandalia, OH, United States	Contract manufacturer	0		0	api.fda.gov
Mach Medical	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Maitland Engineering	South Bend, IN, 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
Medical Modeling - A 3D Systems Company	Littleton, CO, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Medtech LLC	Millington, TN, United States	Contract manufacturer	0		0	api.fda.gov
Mid South Precision	Murfreesboro, TN, 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
Mount MFG	Marquette, MI, United States	Contract manufacturer	0		0	api.fda.gov
Metal Craft Machine & Engineering, Inc.	Elk River, MN, United States	Contract manufacturer	0		0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	api.fda.gov
Nexxt Spine LLC	Noblesville, IN, United States	Contract manufacturer	0		0	api.fda.gov
NGInstruments, Inc dba Avalign Cutting Instruments	Warsaw, IN, United States	Contract manufacturer	0		0	api.fda.gov
Norwood Medical LLC	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Onyx Medical LLC	Memphis, TN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Orthopedic Solutions Alabama LLC	Arab, AL, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Perryman Company	Houston, PA, United States	Contract manufacturer	0		0	api.fda.gov
Prospect Life Sciences	Westminster, CO, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Riverside Machine & Engineering, Inc.	Eau Claire, WI, United States	Contract manufacturer	0		0	api.fda.gov
SCT, Inc.	Franklin Lakes, NJ, United States	Contract manufacturer	0		0	api.fda.gov
Seaway Plastics Engineering, LLC	Brooksville, FL, United States	Contract manufacturer	0		0	api.fda.gov
Symmetry Medical, Inc. - Manchester	Manchester, NH, United States	Contract manufacturer	0		0	api.fda.gov
Sites Medical, LLC	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	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.