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Data / Medical devices / Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented / United States

FDA-registered makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented in the United States: 87 establishments

87 establishments in the United States are registered with the FDA to make Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD). 18 have a 510(k) clearance or PMA approval on file and 7 have a recall event. FDA data exported November 2, 2026.

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Device
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Product code
HSD
Country
United States

Makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Howmedica Osteonics CorpMahwah, NJ, United StatesContract manufacturer, Contract sterilizer, Manufacturer8May 4, 2007010api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer6September 29, 2005010api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer5February 12, 2024000api.fda.gov
Arthrosurface, Inc.W Bridgewater, MA, United StatesManufacturer3April 18, 2018010api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer3December 18, 2008010api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer3December 18, 2008000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer, Manufacturer for export3September 7, 2012000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer2November 26, 2013010api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1February 4, 2000010api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1April 19, 2016000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer1October 30, 2013000api.fda.gov
Biocore9 LLCDenville, NJ, United StatesManufacturer1May 15, 2020000api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesComplaint file establishment, Specification developer1October 15, 1999000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer1May 22, 1995000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer1September 7, 2012000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1September 7, 2012000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1September 7, 2012000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer1November 28, 2007000api.fda.gov
Almark Tool & Manufacturing Company, Inc.Garwood, NJ, United StatesContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Advanced Machine, Inc.Winchester, TN, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer0000api.fda.gov
BiosNesbit, MS, United StatesContract manufacturer0000api.fda.gov
CATALYST ORTHOSCIENCE IncNaples, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Centex Machining, Inc.Round Rock, TX, United StatesContract manufacturer, Manufacturer for export0000api.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
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Exactech SarasotaSarasota, FL, United StatesManufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Fx Shoulder Solutions Inc.Addison, TX, United StatesSpecification developer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Ken-Mar Machine MFG CorpPaterson, NJ, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical, LLCMolalla, OR, United StatesContract manufacturer0000api.fda.gov
LaVezzi Precision, IncBloomingdale, IL, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Mid South PrecisionMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.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
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
On-X Life Technologies Inc.Austin, TX, United StatesManufacturer for export0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, 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
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
ProMade PoC Center for Complex Orthopedic Solutions at HSSManhattan, NY, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Rayco Steel Process, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Restoration Medical PolymersColumbia City, 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
SHOULDER INNOVATIONS, IncGrand Rapids, MI, United StatesRepackager or relabeler, Specification developer0000api.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
TORNIER Inc.Columbia City, IN, United StatesSpecification developer0000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer0020api.fda.gov
restor3d, inc.Durham, NC, United StatesComplaint file establishment, 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.