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Data / Medical devices / Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented / United States

FDA-registered makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented in the United States: 110 establishments

110 establishments in the United States are registered with the FDA to make Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (product code LZO). 21 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 3, 2026.

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Device
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Product code
LZO
Country
United States

Makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer24April 24, 20240110api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Reprocessor22May 15, 2025020api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer, Specification developer19June 16, 20260100api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer18May 19, 2023070api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer, Specification developer16December 8, 2020080api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Manufacturer for export, Repackager or relabeler, Specification developer16January 6, 2023010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer12March 28, 2025010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer12March 28, 2025000api.fda.gov
UOC USA Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export10January 6, 2025000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer8July 19, 2021000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer, Specification developer6September 21, 2011000api.fda.gov
Shalby Advanced Technologies, Inc.El Dorado Hills, CA, United StatesManufacturer6April 10, 2003000api.fda.gov
Encore Medical, L.P.Austin, TX, United StatesManufacturer, Specification developer5February 7, 2025010api.fda.gov
Total Joint Orthopedics, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer5September 23, 2022000api.fda.gov
B-One Ortho, Corp.Cedar Knolls, NJ, United StatesManufacturer4November 15, 2024000api.fda.gov
b-ONE Ortho Corp.Fairfield, NJ, United StatesSpecification developer4November 15, 2024000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesContract manufacturer, Manufacturer3January 18, 1996010api.fda.gov
Maxx Orthopedics Inc.Norristown, PA, United StatesComplaint file establishment, Manufacturer, Specification developer3January 15, 2026000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2April 11, 2011010api.fda.gov
Depuy Orthopaedics, Inc.Raynham, MA, United StatesManufacturer1March 1, 2013000api.fda.gov
Xerxes ArthropedixNaples, FL, United StatesSpecification developer1June 15, 2023000api.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 MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, 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
CPM Medical Consultants, LLC.Farmers Branch, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
ConforMIS, Inc.Wilmington, MA, United StatesManufacturer, Specification developer0000api.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
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Himed, LLCOld Bethpage, NY, United StatesContract manufacturer0000api.fda.gov
Incipio DevicesHuntington, IN, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Ken-Mar Machine MFG CorpPaterson, NJ, United StatesContract manufacturer0000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Lincotek MedicalBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Lincotek Medical LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
Mack Molding CompanyArlington, VT, United StatesContract 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
Materialise USA, LLC.Plymouth, MI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
MendellLakeville, MN, 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
Novosource, LLCMorgantown, WV, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, 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
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
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, 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
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
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
Surgtech, Inc.Westlake, OH, United StatesManufacturer, Specification developer0000api.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 Manufacturing Inc.Lansing, MI, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
T & L Sharpening, Inc.Indiana Beach, IN, United StatesContract manufacturer0000api.fda.gov
Theken Companies, LLCAkron, OH, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Trigon IncorporatedMc Murray, PA, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)Parkrose, OR, United StatesContract manufacturer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer0000api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.fda.gov
Windsor Beach Technologies, Inc.Fairview, PA, United StatesContract manufacturer0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesContract manufacturer0000api.fda.gov
restor3d, inc.Durham, NC, United StatesComplaint file establishment, 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.