Data / Medical devices / Shoulder Prosthesis, Reverse Configuration
Shoulder Prosthesis, Reverse Configuration (PHX): 137 FDA-registered makers in 18 countries
137 establishments in 18 countries are registered with the FDA to make Shoulder Prosthesis, Reverse Configuration (product code PHX, Class 2, 21 CFR 888.3660). 37 of them have a 510(k) clearance or PMA approval on file and 10 have a recall event. The FDA has issued 207 510(k) clearances under this code, the latest on October 22, 2026, and lists 36 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PHX
- Device class
- 2
- Regulation
- 888.3660
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 68 |
| France | 12 |
| Switzerland | 9 |
| Germany | 8 |
| Ireland | 7 |
| Italy | 7 |
| China | 5 |
| United Kingdom | 5 |
| Malaysia | 4 |
| Belgium | 2 |
| Australia | 2 |
| Canada | 2 |
| India | 1 |
| New Zealand | 1 |
| San Marino | 1 |
| Colombia | 1 |
| Ukraine | 1 |
| Taiwan | 1 |
Makers of Shoulder Prosthesis, Reverse Configuration
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 | 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 |
| Tornier S.A.S. | Montbonnot Saint-Martin Isere, France | Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | 18 | April 3, 2026 | 0 | 2 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 16 | April 15, 2026 | 0 | 6 | 0 | api.fda.gov |
| Depuy Ireland UC | Co. Cork Munster, Ireland | Manufacturer, Specification developer | 16 | March 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Encore Medical, L.P. | Austin, TX, United States | Manufacturer | 14 | May 29, 2024 | 0 | 11 | 0 | api.fda.gov |
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Manufacturer | 14 | June 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Manufacturer | 14 | June 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Fx Shoulder Solutions SAS | Viriat Auvergne-Rhone-Alpes, France | Complaint file establishment, Manufacturer, Specification developer | 12 | May 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 11 | April 10, 2023 | 0 | 0 | 0 | api.fda.gov |
| Depuy (ireland) | CO. CORK Munster, Ireland | Manufacturer, Specification developer | 11 | October 4, 2019 | 0 | 0 | 0 | api.fda.gov |
| Limacorporate S.p.A. | Villanova di San Daniele Udine, Italy | Manufacturer | 11 | January 22, 2026 | 0 | 1 | 0 | api.fda.gov |
| FH Industrie | QUIMPER Finistere, France | Manufacturer | 10 | January 9, 2026 | 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 |
| Tornier S.A.S | Montbonnot Saint-Martin Isere, France | Manufacturer | 8 | February 21, 2024 | 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 |
| Depuy Synthes (suzhou) Medical Devices Co., Ltd. | SUZHOU Jiangsu, China | Manufacturer | 6 | September 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Exactech Sarasota | Sarasota, FL, United States | Manufacturer | 6 | July 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 5 | February 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| Stryker Macroom | Co Cork Munster, Ireland | Contract manufacturer, Manufacturer | 5 | November 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 4 | December 2, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zimmer GMBH | WINTERTHUR Zurich, Switzerland | Manufacturer | 4 | January 29, 2020 | 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 |
| Imascap | PLOUZANE Finistere, France | Specification developer | 3 | April 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI, United States | Specification developer | 3 | April 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Waldemar Link GmbH & Co. KG | Norderstedt Schleswig-Holstein, Germany | Manufacturer | 3 | November 16, 2023 | 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer, Manufacturer | 2 | April 15, 2020 | 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 Intl., Ltd. | Leeds, United Kingdom | Manufacturer | 1 | December 15, 2010 | 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 |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Complaint file establishment, Specification developer | 1 | December 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| 3d-Side | Mont Saint Guibert Brabant Wallon, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accentus Medical Ltd | DIDCOT Oxfordshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alm Ortho, Inc. | Scarborough, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aps Materials Inc. Ireland | Waterford Waterford(County), Ireland | Contract 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 | |
| Armbruster GMBH | Steinach Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Automatics Tooling Company Ltd | Salfords Surrey, United Kingdom | 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 | |
| Baechler Feintech AG | Hoelstein Basel-Landschaft, Switzerland | 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 | |
| Cefimeca | La Talaudiere Loire, France | 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 | |
| Chlorophyllic Concepts (opc) Private Limited | Thane Maharashtra, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Croom Precision Medical | Croom Limerick(County), Ireland | 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 | |
| Dot GMBH | Rostock Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eddi Bressan S.R.L. | CORMONS Gorizia, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enztec Limited | CHRISTCHURCH Canterbury, New Zealand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GB Implantat Technologie GMBH | Bochum North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HG Medical GmbH | Raisting Bavaria, Germany | 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 | |
| HPF S.R.L. | Forgaria nel Friuli Friuli Venezia Giulia, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incipio Devices | Huntington, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innotool&greminger AG | Erlen Thurgau, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kico Knee Innovation Company | Frenchs Forest New South Wales, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kammerer Medical Systems GmbH & Co. KG | Stockach Baden-Wurttemberg, Germany | 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 | |
| LSM-MED S.r.l. | Serravalle San Marino Citta, San Marino | 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 | |
| Limacorporate S.p.A. | Calatafimi Segesta (TP) Sicilia, Italy | Contract manufacturer, 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 | |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Group | SAINT-PRIEST Auvergne-Rhone-Alpes, France | 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 | |
| Moser-Baer AG | Sumiswald Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise Colombia S.A.S | Medellin Antioquia, Colombia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise Sdn Bhd | Petaling Jaya Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise Ukraine, Rep. office | Kyiv Kyyiv, Misto, Ukraine | 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 | |
| Oeb S.R.L. | Camposanto Modena, Italy | 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 | |
| Orthoplastics Ltd | Bacup Lancashire, United Kingdom | 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 | |
| PPD Meditech, Div. Of Industries PPD Inc. | Waterville Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precimade | Bourg en Bresse Ain, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Ai Pty Ltd | Brisbane Queensland, Australia | 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 | |
| Sheffield Precision Medical Ltd | Sheffield, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Simon SAS | Bayeux Calvados, France | 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 | |
| Spitrex Orthopedics Switzerland SA | Le Locle Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SQ Products AG | Inwil Luzern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sti Lualdi S.R.L. | Casiacco Pordenone, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Ireland Osteonics | County Cork, Ireland | 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 | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Syntec Scientific Corp. | CHANG HUA Changhua, Taiwan | 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 | |
| Stryker Anngrove | Cork Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou, Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Trauson (Changzhou) Medical Technology Co., Ltd. | Changzhou City Jiangsu, China | 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 | |
| Valtecne SPA | Berbenno di Valtellina Sondrio, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Chaumont S.A.S. | CHAUMONT Haute-Marne, France | 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 | |
| W+S Solutions GMBH | Tuttlingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westlake Plastics Europe | TOURCOING Nord, France | 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 | |
| Zimmer Cas | Montreal, Quebec, Canada | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| implantcast GmbH | Buxtehude Lower Saxony, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 22, 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.