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Data / Medical devices / Staple, Fixation, Bone / United States

FDA-registered makers of Staple, Fixation, Bone in the United States: 108 establishments

108 establishments in the United States are registered with the FDA to make Staple, Fixation, Bone (product code JDR). 41 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 2, 2026.

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Device
Staple, Fixation, Bone
Product code
JDR
Country
United States

Makers of Staple, Fixation, Bone in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer16June 29, 2007010api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer13February 26, 2020020api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer11October 2, 2015020api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer6September 1, 2026000api.fda.gov
Medartis Inc.Warsaw, IN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer5August 30, 2023000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesManufacturer4August 16, 2019010api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer4April 11, 2025000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer4August 6, 2026010api.fda.gov
Treace Medical Concepts, Inc.Ponte Vedra, FL, United StatesManufacturer4December 26, 2024000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer4May 7, 2021010api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Specification developer3August 19, 2022000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer3April 3, 2000000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer, Manufacturer for export3May 7, 2021000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesManufacturer2October 29, 2007000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer2June 4, 1993000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer2July 11, 2014000api.fda.gov
RMR ORTHO, IncSan Antonio, TX, United StatesComplaint file establishment, Specification developer2January 12, 2024000api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer2April 3, 2000010api.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
Vilex LLCMcminnville, TN, United StatesManufacturer2August 11, 2023000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1October 24, 2011000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1February 1, 1995000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer1July 10, 1996000api.fda.gov
Exactech, Inc.Gainesville, FL, United StatesManufacturer1May 16, 2017000api.fda.gov
Exotoe LLCCharlotte, NC, United StatesManufacturer, Specification developer1January 11, 2018000api.fda.gov
Extremity Medical, LLCParsippany, NJ, United StatesSpecification developer1December 19, 2014000api.fda.gov
F & A FoundationTulsa, OK, United StatesSpecification developer1April 6, 2018010api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1October 15, 2018000api.fda.gov
Gramercy Extremity Orthopedics, LLC.Richardson, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1January 11, 2019000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesManufacturer, Specification developer1October 24, 2016020api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer1October 1, 2001000api.fda.gov
Metric Medical Devices, Inc.Helotes, TX, United StatesManufacturer, Specification developer1January 3, 2013000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer1April 4, 2019000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1May 3, 2013000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Specification developer1March 13, 1997000api.fda.gov
Trax Surgical, Inc.Stoughton, MA, United StatesManufacturer1May 14, 2025000api.fda.gov
Trimed, Inc.Santa Clarita, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1July 1, 2019010api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1October 20, 2022000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1October 20, 2022000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer1October 1, 2001000api.fda.gov
Almark Tool & Manufacturing Company, Inc.Garwood, NJ, United StatesContract manufacturer0000api.fda.gov
Arcamed, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalPlymouth, MA, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
Blaze Biotech, LLCSan Antonio, TX, United StatesContract manufacturer0000api.fda.gov
Conextions IncSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer0000api.fda.gov
HG Medical Usa, LLCHolland, MI, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Integrity SystemsOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Kapstone ManufacturingCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Lifestyle Medical ManufacturingLogan, UT, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Mach MedicalColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Matrix Machining Technologies, Inc.Memphis, TN, United StatesContract manufacturer0000api.fda.gov
Medical Component SpecialistsBellingham, MA, United StatesContract manufacturer0000api.fda.gov
Medin Technologies, Inc.Totowa, NJ, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Mount MFGMarquette, MI, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Peridot CorporationPleasanton, CA, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesRome City, IN, 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
Precision Edge Surgical Products Co LLCBoyne City, MI, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products, LLCAngola, IN, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, 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
Responsive ArthroscopyMinneapolis, MN, United StatesSpecification developer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
RTI Surgical, Inc. (dba RTI Biologics, Inc.)Alachua, FL, United StatesManufacturer0000api.fda.gov
Resonetics, LLCBethel, CT, United StatesContract manufacturer0000api.fda.gov
Seaway Plastics Engineering, LLCBrooksville, FL, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Spectrum Plastics GroupSaint Louis Park, MN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, 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.