Data / Medical devices / Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented / United States

FDA-registered makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented in the United States: 25 establishments

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

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

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Device: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Product code: PAO
Country: United States

Makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Class I	Source
TORNIER Inc.	Columbia City, IN, United States	Specification developer	1	September 11, 2020	0	0	api.fda.gov
Tornier, Inc.	Bloomington, MN, United States	Complaint file establishment, Manufacturer	1	September 11, 2020	1	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Avalign Delivery Systems Division	Greenwood, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	0		2	1	api.fda.gov
C+a Tool Engineering, Inc.	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Specification developer	0		0	0	api.fda.gov
Donson Machine Company	Alsip, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	0		0	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	0		0	0	api.fda.gov
Exactech, Inc.	Gainesville, FL, United States	Manufacturer	0		0	0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Millstone Medical Outsourcing LLC	Olive Branch, MS, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	0	api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, United States	Contract manufacturer	0		0	0	api.fda.gov
Restoration Medical Polymers	Columbia City, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	0	api.fda.gov
Turnco Tool & Instrument, Inc.	Georgetown, TX, United States	Contract manufacturer	0		0	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	0		0	0	api.fda.gov
rms Surgical	Anoka, MN, United States	Contract manufacturer	0		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.