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Data / Medical devices / Staple, Fixation, Bone

Staple, Fixation, Bone (JDR): 157 FDA-registered makers in 11 countries

157 establishments in 11 countries are registered with the FDA to make Staple, Fixation, Bone (product code JDR, Class 2, 21 CFR 888.3030). 56 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 233 510(k) clearances under this code, the latest on September 1, 2026, and lists 18 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JDR
Device class
2
Regulation
888.3030
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States108
Germany12
France10
Switzerland8
United Kingdom5
China5
Malaysia3
Finland2
Mexico2
Costa Rica1
Taiwan1

Makers of Staple, Fixation, Bone

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

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
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandSpecification developer7February 26, 2020000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer6September 1, 2026000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandComplaint file establishment, Manufacturer, Specification developer6June 10, 2022010api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer5June 29, 2007000api.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
In2Bones SASSaint-Priest Rhone, FranceExporter to the US, Specification developer2March 21, 2016000api.fda.gov
Linvatec CorporationLargo, FL, United StatesManufacturer2June 4, 1993000api.fda.gov
NovastepRENNES Bretagne, FranceManufacturer2December 4, 2023000api.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
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer2May 11, 2015000api.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
Xiros LtdYEADON Leeds, United KingdomManufacturer2July 13, 2001000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1October 24, 2011000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1February 1, 1995000api.fda.gov
Arthrocare CorporationCoyol Alajuela, Costa RicaManufacturer1April 3, 2000000api.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
GLW Europe GmbHWurmlingen Baden-Wurttemberg, GermanySpecification developer1December 4, 2023000api.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
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer1April 12, 2021000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer1April 12, 2021000api.fda.gov
Medartis AGBASEL Basel-Stadt, SwitzerlandManufacturer1August 16, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer1October 1, 2001000api.fda.gov
Merete GMBHBerlin, GermanySpecification developer1December 28, 2015010api.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
Ortho Solutions UK LimitedMaldon Essex, United KingdomComplaint file establishment, Manufacturer, Specification developer1February 23, 2024000api.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
XL Precision Technologies LtdStockton on Tees Stockton-on-Tees, United KingdomContract manufacturer, Exporter to the US1November 19, 2014000api.fda.gov
Almark Tool & Manufacturing Company, Inc.Garwood, NJ, United StatesContract manufacturer0000api.fda.gov
AMF, SarlLury sur Arnon Cher, FranceContract manufacturer0000api.fda.gov
Arcamed, LLCIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Arctic Biomaterials OYTampere Pirkanmaa, FinlandContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalPlymouth, MA, United StatesContract manufacturer0000api.fda.gov
Automatics Tooling Company LtdSalfords Surrey, United KingdomContract manufacturer0000api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Aristotech Industries GmbHBerlin, GermanyContract 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
BIEDERMANN MOTECH GMBH & Co. KGVS-SCHWENNINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Biocomposites Ltd.Keele Staffordshire, United KingdomManufacturer0000api.fda.gov
Blaze Biotech, LLCSan Antonio, TX, United StatesContract manufacturer0000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract 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
Ethicon, Inc.CIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
ForecreuMalicorne Allier, FranceContract manufacturer0000api.fda.gov
Hangzhou Sino-Mim Technology Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
HG Medical Usa, LLCHolland, MI, United StatesContract manufacturer0000api.fda.gov
HG Medical GmbHRaisting Bavaria, GermanyContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer0000api.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
Kingj Medical Co., LtdZhangjiagang Jiangsu, ChinaContract 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
Marle Finishing SASLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Matrix Machining Technologies, Inc.Memphis, TN, United StatesContract manufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medical Component SpecialistsBellingham, MA, United StatesContract manufacturer0000api.fda.gov
MedicatechnologieCHARTRES-DE-BRETAGNE Ille-et-Vilaine, FranceContract 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
Miing Wei Co., Ltd.Tsao-Twon Nantou, TaiwanContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
MK medical GmbHEmmingen-Liptingen Baden-Wurttemberg, GermanyContract 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
Puracon GMBHRosenheim Bavaria, GermanyContract 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
RapharinGENAS Rhone, FranceContract 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
Ruetschi Technology AGMuntelier Fribourg, SwitzerlandContract manufacturer0000api.fda.gov
Resonetics, LLCBethel, CT, United StatesContract manufacturer0000api.fda.gov
Seaway Plastics Engineering, LLCBrooksville, FL, United StatesContract manufacturer0000api.fda.gov
Selenium Medical S.A.S.La Rochelle Charente-Maritime, FranceContract manufacturer0000api.fda.gov
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer0000api.fda.gov
Stryker Trauma GMBHSCHOENKIRCHEN Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
Suzhou Kangli Orthopaedics Instrument Co., Ltd.Zhangjiagang City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Sanbor Medical Xiamen, Inc.Xiamen Fujian, ChinaContract manufacturer0000api.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
VCN TechnologiesSAINT-PRIEST Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Z-Medical GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov

Updated September 1, 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.