Data / Medical devices / Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented / United States

FDA-registered makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented in the United States: 36 establishments

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

36 establishments in the United States are registered with the FDA to make Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented (product code MBF). 7 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, Uncemented
Product code: MBF
Country: United States

Makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented in the United States

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
Biomet, Inc.	Warsaw, IN, United States	Manufacturer	11	October 28, 2020	6	api.fda.gov
Depuy Orthopaedics, Inc.	Warsaw, IN, United States	Manufacturer, Specification developer	7	November 13, 2023	0	api.fda.gov
DePuy Mitek, Inc.	Raynham, MA, United States	Specification developer	5	June 8, 2022	0	api.fda.gov
Zimmer, Inc.	Warsaw, IN, United States	Contract manufacturer, Manufacturer	5	April 13, 2026	0	api.fda.gov
Encore Medical, L.P.	Austin, TX, United States	Manufacturer	1	September 30, 2008	1	api.fda.gov
SHOULDER INNOVATIONS, Inc	Grand Rapids, MI, United States	Specification developer	1	October 23, 2018	0	api.fda.gov
Synthes (USA) Products LLC	West Chester, PA, United States	Complaint file establishment, Specification developer	1	February 5, 2009	0	api.fda.gov
Aps Materials, Inc.	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Arthrex, Inc.	Naples, FL, United States	Specification developer	0		0	api.fda.gov
Arthrex Manufacturing Inc.	Pendleton, SC, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Arthrex, Inc.	Ave Maria, FL, United States	Contract manufacturer, Contract sterilizer	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
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
Dot America, Inc.	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Incipio Devices	Huntington, IN, United States	Contract manufacturer	0		0	api.fda.gov
Jabil Inc. (Monument)	Monument, CO, United States	Contract manufacturer	0		0	api.fda.gov
LH Medical Corporation	Fort Wayne, IN, United States	Contract manufacturer	0		0	api.fda.gov
LaVezzi Precision, Inc	Bloomingdale, IL, United States	Contract manufacturer	0		0	api.fda.gov
Lincotek Medical	Bartlett, TN, United States	Contract manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
Micropulse Inc	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical - Dayton	Dayton, OH, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Castleton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Paragon Medical Inc.	Smithfield, UT, United States	Contract manufacturer	0		0	api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSS	Manhattan, NY, United States	Contract manufacturer	0		0	api.fda.gov
Restoration Medical Polymers	Columbia City, IN, United States	Contract manufacturer	0		0	api.fda.gov
Revelation Medical Devices, LLC	Auburn, IN, United States	Contract manufacturer	0		0	api.fda.gov
RMS Co.	Minneapolis, MN, United States	Contract manufacturer	0		0	api.fda.gov
Single Source Medical LLC	Churubusco, IN, United States	Contract manufacturer	0		0	api.fda.gov
Structure Medical, LLC.	Mooresville, NC, United States	Contract manufacturer	0		0	api.fda.gov
Viant Medical, LLC	Fort Wayne, 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.