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Data / Medical devices / Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented / United States

FDA-registered makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented in the United States: 82 establishments

82 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (product code KWY). 22 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 3, 2026.

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Device
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Product code
KWY
Country
United States

Makers of Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biomet, Inc.Warsaw, IN, United StatesManufacturer5October 31, 2008040api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer4July 7, 2005000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Specification developer4August 27, 2004050api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer3September 18, 1995000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer3December 5, 2001010api.fda.gov
UOC USA Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export3April 7, 2016000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer2April 17, 2020000api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2August 25, 2025000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesManufacturer, Manufacturer for export2September 29, 2006000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer2November 5, 2012000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2January 23, 2003020api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2January 23, 2003000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer1July 8, 2008000api.fda.gov
B-One Ortho, Corp.Cedar Knolls, NJ, United StatesSpecification developer1April 13, 2026000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer, Manufacturer1December 3, 2010010api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer1August 9, 1995010api.fda.gov
Surgtech, Inc.Westlake, OH, United StatesManufacturer, Specification developer1June 14, 2018000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1January 23, 2003000api.fda.gov
Theken Companies, LLCAkron, OH, United StatesComplaint file establishment, Specification developer1September 17, 2019000api.fda.gov
Total Joint Orthopedics, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer1January 28, 2015010api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesManufacturer1January 30, 1984010api.fda.gov
b-ONE Ortho Corp.Fairfield, NJ, United StatesSpecification developer1April 13, 2026000api.fda.gov
Abbott LaboratoriesIrving, TX, United StatesSpecification developer0000api.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 - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalPlymouth, MA, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
C&A Tool Engineering, Inc. Auburn PlantAuburn, IN, United StatesContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, 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
Cep Bio-Coat, LLCFarmington Hills, MI, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Dot America, Inc.Columbia City, IN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer0010api.fda.gov
Himed, LLCOld Bethpage, NY, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations Inc.Spartanburg, SC, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Mack Molding CompanyArlington, VT, United StatesContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Marson Medical, Inc.Paramus, NJ, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, 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
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Onkos Surgical, Inc.Parsippany, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics-ChelseaChelsea, MI, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Osteoremedies, LLCMemphis, TN, United StatesSpecification developer0000api.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
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Polymer CorporationMiddletown, CT, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, 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
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.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, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Trelleborg Sealing Solutions LitchfieldLitchfield, MN, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.