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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

CountryMakers
United States68
France12
Switzerland9
Germany8
Ireland7
Italy7
China5
United Kingdom5
Malaysia4
Belgium2
Australia2
Canada2
India1
New Zealand1
San Marino1
Colombia1
Ukraine1
Taiwan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer20March 11, 2026010api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer19December 2, 2022000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer19April 14, 2026080api.fda.gov
Tornier S.A.S.Montbonnot Saint-Martin Isere, FranceComplaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer, Specification developer18April 3, 2026020api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer16April 15, 2026060api.fda.gov
Depuy Ireland UCCo. Cork Munster, IrelandManufacturer, Specification developer16March 11, 2026000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer14May 29, 20240110api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer14June 10, 2026000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer14June 10, 2026000api.fda.gov
Fx Shoulder Solutions SASViriat Auvergne-Rhone-Alpes, FranceComplaint file establishment, Manufacturer, Specification developer12May 15, 2024000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer11April 10, 2023000api.fda.gov
Depuy (ireland)CO. CORK Munster, IrelandManufacturer, Specification developer11October 4, 2019000api.fda.gov
Limacorporate S.p.A.Villanova di San Daniele Udine, ItalyManufacturer11January 22, 2026010api.fda.gov
FH IndustrieQUIMPER Finistere, FranceManufacturer10January 9, 2026000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer10June 12, 2026030api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer10June 16, 2026010api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer9June 12, 2026000api.fda.gov
Tornier S.A.SMontbonnot Saint-Martin Isere, FranceManufacturer8February 21, 2024000api.fda.gov
CATALYST ORTHOSCIENCE IncNaples, FL, United StatesManufacturer, Repackager or relabeler, Specification developer6April 5, 2024000api.fda.gov
Depuy Synthes (suzhou) Medical Devices Co., Ltd.SUZHOU Jiangsu, ChinaManufacturer6September 15, 2021000api.fda.gov
Exactech SarasotaSarasota, FL, United StatesManufacturer6July 18, 2024000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer, Manufacturer5February 19, 2021000api.fda.gov
Stryker MacroomCo Cork Munster, IrelandContract manufacturer, Manufacturer5November 15, 2016000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer4December 2, 2019000api.fda.gov
Zimmer GMBHWINTERTHUR Zurich, SwitzerlandManufacturer4January 29, 2020000api.fda.gov
Fx Shoulder Solutions Inc.Addison, TX, United StatesSpecification developer3June 5, 2023010api.fda.gov
ImascapPLOUZANE Finistere, FranceSpecification developer3April 3, 2026000api.fda.gov
SHOULDER INNOVATIONS, IncGrand Rapids, MI, United StatesSpecification developer3April 13, 2026000api.fda.gov
Waldemar Link GmbH & Co. KGNorderstedt Schleswig-Holstein, GermanyManufacturer3November 16, 2023000api.fda.gov
restor3d, inc.Durham, NC, United StatesComplaint file establishment, Manufacturer3July 1, 2026010api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer2March 22, 2018000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer, Manufacturer2April 15, 2020000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer1June 24, 2021000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1November 25, 2014000api.fda.gov
Depuy Intl., Ltd.Leeds, United KingdomManufacturer1December 15, 2010000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesSpecification developer1February 24, 2020000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandComplaint file establishment, Specification developer1December 27, 2013000api.fda.gov
3d-SideMont Saint Guibert Brabant Wallon, BelgiumManufacturer0000api.fda.gov
Accentus Medical LtdDIDCOT Oxfordshire, United KingdomContract manufacturer0000api.fda.gov
Alm Ortho, Inc.Scarborough, ME, United StatesManufacturer0000api.fda.gov
Aps Materials Inc. IrelandWaterford Waterford(County), IrelandContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Armbruster GMBHSteinach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Automatics Tooling Company LtdSalfords Surrey, United KingdomContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
BiosNesbit, MS, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer0000api.fda.gov
Chlorophyllic Concepts (opc) Private LimitedThane Maharashtra, IndiaContract manufacturer0000api.fda.gov
Croom Precision MedicalCroom Limerick(County), IrelandContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Dot America, Inc.Columbia City, IN, United StatesContract manufacturer0000api.fda.gov
Dot GMBHRostock Mecklenburg-Western Pomerania, GermanyContract manufacturer0000api.fda.gov
Eddi Bressan S.R.L.CORMONS Gorizia, ItalyContract manufacturer0000api.fda.gov
Enztec LimitedCHRISTCHURCH Canterbury, New ZealandContract manufacturer0000api.fda.gov
GB Implantat Technologie GMBHBochum North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
HG Medical GmbHRaisting Bavaria, GermanyContract manufacturer0000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
HPF S.R.L.Forgaria nel Friuli Friuli Venezia Giulia, ItalyContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Innotool&greminger AGErlen Thurgau, SwitzerlandContract manufacturer0000api.fda.gov
Kico Knee Innovation CompanyFrenchs Forest New South Wales, AustraliaManufacturer0000api.fda.gov
Kammerer Medical Systems GmbH & Co. KGStockach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
LSM-MED S.r.l.Serravalle San Marino Citta, San MarinoContract manufacturer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract manufacturer0000api.fda.gov
Limacorporate S.p.A.Calatafimi Segesta (TP) Sicilia, ItalyContract manufacturer, Manufacturer0000api.fda.gov
Lincotek MedicalBartlett, TN, United StatesContract manufacturer0000api.fda.gov
LinkBio Corp.Dover, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Materialise N.V.LEUVEN Vlaams Brabant, BelgiumManufacturer0000api.fda.gov
Medical GroupSAINT-PRIEST Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Moser-Baer AGSumiswald Bern, SwitzerlandContract manufacturer0000api.fda.gov
Materialise Colombia S.A.SMedellin Antioquia, ColombiaManufacturer0000api.fda.gov
Materialise Sdn BhdPetaling Jaya Selangor, MalaysiaManufacturer0000api.fda.gov
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer0000api.fda.gov
Materialise Ukraine, Rep. officeKyiv Kyyiv, Misto, UkraineManufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Oeb S.R.L.Camposanto Modena, ItalyContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orthoplastics LtdBacup Lancashire, United KingdomContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
PPD Meditech, Div. Of Industries PPD Inc.Waterville Quebec, CanadaContract manufacturer0000api.fda.gov
PrecimadeBourg en Bresse Ain, FranceContract manufacturer0000api.fda.gov
Precision Ai Pty LtdBrisbane Queensland, AustraliaContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSSManhattan, NY, United StatesContract manufacturer0000api.fda.gov
Rayco Steel Process, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Revelation Medical Devices, LLCAuburn, IN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Sheffield Precision Medical LtdSheffield, United KingdomContract manufacturer0000api.fda.gov
Simon SASBayeux Calvados, FranceContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Spitrex Orthopedics Switzerland SALe Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
SQ Products AGInwil Luzern, SwitzerlandContract manufacturer0000api.fda.gov
Sti Lualdi S.R.L.Casiacco Pordenone, ItalyContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Stryker Ireland OsteonicsCounty Cork, IrelandContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Syntec Scientific Corp.CHANG HUA Changhua, TaiwanContract manufacturer0000api.fda.gov
Sites Medical, LLCColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Stryker AnngroveCork Munster, IrelandContract manufacturer0000api.fda.gov
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd.Changzhou, Jiangsu, ChinaContract manufacturer0000api.fda.gov
Stryker Trauson (Changzhou) Medical Technology Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Valtecne SPABerbenno di Valtellina Sondrio, ItalyContract manufacturer0000api.fda.gov
Viant Chaumont S.A.S.CHAUMONT Haute-Marne, FranceContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
W+S Solutions GMBHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Westlake Plastics EuropeTOURCOING Nord, FranceContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesContract manufacturer0000api.fda.gov
Zimmer CasMontreal, Quebec, CanadaManufacturer, Specification developer0000api.fda.gov
implantcast GmbHBuxtehude Lower Saxony, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.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.