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Data / Medical devices / Prosthesis, Hip, Hemi-, Femoral, Metal / United States

FDA-registered makers of Prosthesis, Hip, Hemi-, Femoral, Metal in the United States: 58 establishments

58 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL). 17 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Prosthesis, Hip, Hemi-, Femoral, Metal
Product code
KWL
Country
United States

Makers of Prosthesis, Hip, Hemi-, Femoral, Metal in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Osteoremedies, LLCMemphis, TN, United StatesSpecification developer6December 23, 2025000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer5October 21, 2022060api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2January 19, 1999000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesManufacturer2March 23, 1992000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2April 25, 1994010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2April 25, 1994000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer, Manufacturer1December 1, 1989000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer1May 15, 2026020api.fda.gov
E. Bac Si Imports LLCEllensburg, WA, United StatesComplaint file establishment, Specification developer1February 27, 1989000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer1December 18, 1997000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer1August 21, 1998000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1August 21, 1998000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer1January 27, 2005000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer1April 1, 2003000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1April 25, 1994000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1February 27, 1986000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Specification developer1August 12, 1981000api.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
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
Exactech, Inc.Gainesville, FL, United StatesManufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Himed, LLCOld Bethpage, NY, United StatesContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Mack Molding CompanyArlington, VT, 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
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, 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
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Polymer CorporationMiddletown, CT, 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
Smith & Nephew Inc.Oklahoma City, OK, 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
Trigon IncorporatedMc Murray, PA, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Trelleborg Sealing Solutions LitchfieldLitchfield, MN, United StatesContract manufacturer0000api.fda.gov
UOC USA Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesManufacturer0000api.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.