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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

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
Biomet, Inc.Warsaw, IN, United StatesManufacturer16April 15, 2026060api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer14May 29, 20240110api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer11April 10, 2023000api.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
CATALYST ORTHOSCIENCE IncNaples, FL, United StatesManufacturer, Repackager or relabeler, Specification developer6April 5, 2024000api.fda.gov
Exactech SarasotaSarasota, FL, United StatesManufacturer6July 18, 2024000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer4December 2, 2019000api.fda.gov
Fx Shoulder Solutions Inc.Addison, TX, United StatesSpecification developer3June 5, 2023010api.fda.gov
SHOULDER INNOVATIONS, IncGrand Rapids, MI, United StatesSpecification developer3April 13, 2026000api.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
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer1June 24, 2021000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1November 25, 2014000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesSpecification developer1February 24, 2020000api.fda.gov
Alm Ortho, Inc.Scarborough, ME, United StatesManufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract 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
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
Centex Machining, Inc.Round Rock, TX, United StatesContract 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
Howmedica Osteonics CorpMahwah, NJ, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract 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
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
Materialise USA, LLC.Plymouth, MI, United StatesManufacturer0000api.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
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract 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
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Sites Medical, LLCColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.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.