Data / Medical devices / Shoulder Prosthesis, Reverse Configuration / United States
FDA-registered makers of Shoulder Prosthesis, Reverse Configuration in the United States: 68 establishments
68 establishments in the United States are registered with the FDA to make Shoulder Prosthesis, Reverse Configuration (product code PHX). 19 have a 510(k) clearance or PMA approval on file and 8 have a recall event. FDA data exported November 2, 2026.
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- Device
- Shoulder Prosthesis, Reverse Configuration
- Product code
- PHX
- Country
- United States
Makers of Shoulder Prosthesis, Reverse Configuration in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 20 | March 11, 2026 | 0 | 1 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 19 | December 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 19 | April 14, 2026 | 0 | 8 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 16 | April 15, 2026 | 0 | 6 | 0 | api.fda.gov |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 14 | May 29, 2024 | 0 | 11 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 11 | April 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 10 | June 12, 2026 | 0 | 3 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 10 | June 16, 2026 | 0 | 1 | 0 | api.fda.gov |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 9 | June 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| CATALYST ORTHOSCIENCE Inc | Naples, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 6 | April 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Exactech Sarasota | Sarasota, FL, United States | Manufacturer | 6 | July 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 4 | December 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Fx Shoulder Solutions Inc. | Addison, TX, United States | Specification developer | 3 | June 5, 2023 | 0 | 1 | 0 | api.fda.gov |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI, United States | Specification developer | 3 | April 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| restor3d, inc. | Durham, NC, United States | Complaint file establishment, Manufacturer | 3 | July 1, 2026 | 0 | 1 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 2 | March 22, 2018 | 0 | 0 | 0 | api.fda.gov |
| Arthrosurface, Inc. | W Bridgewater, MA, United States | Manufacturer | 1 | June 24, 2021 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 1 | November 25, 2014 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Raynham, MA, United States | Specification developer | 1 | February 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Alm Ortho, Inc. | Scarborough, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biopro, Inc. | Port Huron, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bios | Nesbit, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C+a Tool Engineering, Inc. | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centex Machining, Inc. | Round Rock, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dot America, Inc. | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL REmmele | Big Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LaVezzi Precision, Inc | Bloomingdale, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lincotek Medical | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LinkBio Corp. | Dover, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedics-Chelsea | Chelsea, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Dayton | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Castleton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Precision Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ProMade PoC Center for Complex Orthopedic Solutions at HSS | Manhattan, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayco Steel Process, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Revelation Medical Devices, LLC | Auburn, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SCT, Inc. | Franklin Lakes, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Single Source Medical LLC | Churubusco, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sites Medical, LLC | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trilliant Surgical LLC | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 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.