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Data / Medical devices / Pin, Fixation, Smooth / United States

FDA-registered makers of Pin, Fixation, Smooth in the United States: 114 establishments

114 establishments in the United States are registered with the FDA to make Pin, Fixation, Smooth (product code HTY). 53 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 2, 2026.

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Get makers of this device in the United StatesWatch these makers
Device
Pin, Fixation, Smooth
Product code
HTY
Country
United States

Makers of Pin, Fixation, Smooth in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biomet, Inc.Warsaw, IN, United StatesManufacturer11May 22, 2024040api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer10June 29, 2020000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer7January 9, 2014000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer5May 17, 2013000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer, Specification developer4September 12, 2014000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer4June 24, 2025000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer3December 19, 2011000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer2September 6, 2022000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer2December 19, 2007010api.fda.gov
Arrowhead De LLCPeachtree City, GA, United StatesSpecification developer2December 12, 2011010api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer2March 5, 2018010api.fda.gov
Simpex Medical, Inc.Fort Mill, SC, United StatesSpecification developer2April 12, 1991000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer2August 21, 2014000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer2August 21, 2014000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler2July 6, 2023000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer2October 24, 2014000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer2May 1, 2015010api.fda.gov
A.M. Surgical, Inc.Nashua, NH, United StatesSpecification developer1May 18, 2018000api.fda.gov
Armis Biopharma, Inc.Fort Collins, CO, United StatesComplaint file establishment, Specification developer1November 17, 2020000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer1April 9, 2015000api.fda.gov
Bioaccess, Inc.Baltimore, MD, United StatesSpecification developer1October 20, 1986000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesManufacturer1March 18, 2009000api.fda.gov
Brasseler U.S.A. Medical, LLCSavannah, GA, United StatesManufacturer1February 22, 1994020api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer1March 7, 1986000api.fda.gov
Diamond OrthopedicGastonia, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1September 10, 2010000api.fda.gov
Graham Medical Technologies, L.L.C. d.b.a. GraMedicaRochester, MI, United StatesManufacturer, Specification developer1May 29, 2015000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesSpecification developer1May 4, 2021000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Specification developer1September 14, 2023000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler1March 25, 2003000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer1April 28, 2006000api.fda.gov
Metric Medical Devices, Inc.Helotes, TX, United StatesManufacturer, Specification developer1January 13, 2016000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesManufacturer1October 20, 1986020api.fda.gov
Medartis Inc.Warsaw, IN, United StatesContract manufacturer, Repackager or relabeler1September 23, 2009000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer1June 11, 2025000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer, Manufacturer1February 17, 2022000api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1September 30, 2021000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer1October 20, 1986000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1July 30, 2004020api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1February 28, 2011000api.fda.gov
Spinal Resources IncFort Lauderdale, FL, United StatesComplaint file establishment, Specification developer1March 9, 2016000api.fda.gov
Starr Frame LLCRichardson, TX, United StatesSpecification developer1October 10, 2008000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer1April 17, 2015000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer1April 17, 2015000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1July 30, 2004000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1July 30, 2004000api.fda.gov
Stryker EndoscopyGreenwood Village, CO, United StatesSpecification developer1April 17, 2015000api.fda.gov
Toetal Solutions, IncMalvern, PA, United StatesSpecification developer1December 29, 2025000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1May 25, 2007000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1May 25, 2007000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesManufacturer1June 4, 2012010api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1July 6, 2023000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer1October 24, 2014000api.fda.gov
restor3d, inc.Durham, NC, United StatesManufacturer1January 4, 2022000api.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
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.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
Cathtek LLCWalkertown, NC, United StatesContract manufacturer0000api.fda.gov
Conmed CorporationUtica, NY, United StatesContract manufacturer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Fort Wayne Metals Research Products, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medical Component SpecialistsBellingham, MA, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, United StatesContract manufacturer0000api.fda.gov
MedulocDel Mar, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Machining Midtown LLCAtlanta, GA, United StatesContract manufacturer0000api.fda.gov
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orthonovis, Inc.Palm Coast, FL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer0000api.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
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Quadm Technologies, LLCHamilton, NJ, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Red Star Contract Manufacturing Inc.Larwill, 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
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Structure Medical, LLC.Naples, FL, 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
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Spectrum Plastics GroupSaint Louis Park, MN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Teslake, Inc.San Diego, CA, United StatesSpecification developer0000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Tegra Medical - Franklin, MAFranklin, MA, United StatesContract manufacturer0000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer0000api.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.