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Data / Medical devices / Pin, Fixation, Threaded

Pin, Fixation, Threaded (JDW): 130 FDA-registered makers in 13 countries

130 establishments in 13 countries are registered with the FDA to make Pin, Fixation, Threaded (product code JDW, Class 2, 21 CFR 888.3040). 33 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 94 510(k) clearances under this code, the latest on February 10, 2026, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
JDW
Device class
2
Regulation
888.3040
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States87
Germany10
China7
Switzerland6
Italy5
France5
Malaysia3
United Kingdom2
South Korea1
Netherlands1
India1
Austria1
Taiwan1

Makers of Pin, Fixation, Threaded

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
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer10December 8, 2022000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer9February 11, 2022020api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer7February 17, 2011020api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer, Specification developer7October 5, 2021000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer7February 11, 2022000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer4December 8, 2022000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer4April 12, 2004000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer4April 12, 2004000api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer2December 16, 1996000api.fda.gov
MedicalplasticMILANO Lombardy, ItalySpecification developer2June 7, 2012000api.fda.gov
Orthofix SRLBUSSOLENGO Verona, ItalyManufacturer2March 18, 1998020api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesRepackager or relabeler, Specification developer2March 18, 1998000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2February 13, 2017000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesSpecification developer2March 15, 2002000api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer2November 8, 2007000api.fda.gov
Aap Implantate AGBerlin, GermanyManufacturer1October 17, 2013000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1June 16, 2009000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesManufacturer, Specification developer1July 7, 2015000api.fda.gov
Biopro, Inc.Port Huron, MI, United StatesManufacturer1November 6, 1996000api.fda.gov
BK Meditech Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer1July 26, 2006000api.fda.gov
BioDynamikLake Forest, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1January 22, 2025000api.fda.gov
Brasseler U.S.A. Medical, LLCSavannah, GA, United StatesManufacturer1March 7, 1995000api.fda.gov
Citieffe SRLCalderara di Reno Bologna, ItalyManufacturer1July 7, 2015000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesSpecification developer1February 9, 1984000api.fda.gov
Hand Biomechanics Lab, Inc.Sacramento, CA, United StatesManufacturer1November 8, 1999000api.fda.gov
MedulocDel Mar, CA, United StatesComplaint file establishment, Specification developer1October 29, 2025000api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer1October 25, 2018000api.fda.gov
Summa Orthopaedics Inc.Berwyn, PA, United StatesComplaint file establishment, Specification developer1May 30, 2014000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1November 20, 2000000api.fda.gov
Teslake, Inc.San Diego, CA, United StatesSpecification developer1December 26, 2019000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1March 6, 2003000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer1March 6, 2003000api.fda.gov
Vilex LLCMcminnville, TN, United StatesManufacturer, Repackager or relabeler1July 23, 2014000api.fda.gov
3D MEDICAL MANUFACTURING, INC. (dba Tecomet)Riviera Beach, FL, United StatesContract manufacturer0000api.fda.gov
Addn Solutions GMBH & Co. KGWurmlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Aike (shanghai) Medical Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
ARCH Medical Solutions - ElmhurstElmhurst, IL, 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
Autocam MedicalPlymouth, MA, United StatesContract manufacturer0000api.fda.gov
Automatics Tooling Company LtdSalfords Surrey, United KingdomContract manufacturer0000api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
B & J Medical LLCKendallville, IN, United StatesContract manufacturer0000api.fda.gov
Baat Medical Products B.V.Hengelo Overijssel, NetherlandsSpecification developer0000api.fda.gov
Biomet FranceValence Drome, FranceManufacturer0000api.fda.gov
Canwell Medical Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov
Cep Bio-Coat, LLCFarmington Hills, MI, United StatesContract manufacturer0000api.fda.gov
CREATEC GmbH & CO. KGFRIEDRICHSHAFEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Changzhou Biomet Medical Devices Co., Ltd.Changzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer0000api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision MachiningBrookpark, OH, United StatesContract manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Diamond OrthopedicGastonia, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Five Star Manufacturing, Inc.New Bedford, MA, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyManufacturer0000api.fda.gov
GPC Medical LimitedGhaziabad Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hofmann S.R.L.MONZA (MI) Monza e Brianza, ItalyContract manufacturer0000api.fda.gov
Huron Tool & Cutter GrindingFarmingdale, NY, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
I.T.S. GMBHLASSNITZHOEHE Steiermark, AustriaManufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Intelivation Technologies, LLCPlymouth Meeting, PA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
In2Bones SASSaint-Priest Rhone, FranceExporter to the US, Specification developer0000api.fda.gov
Instrumed International Inc dba Avalign German Specialty InstrumentsSchaumburg, IL, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
JMG Machine, Inc.La Mirada, CA, United StatesContract manufacturer, 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
Jabil Switzerland Manufacturing GmbH (Raron)Raron Valais, SwitzerlandContract manufacturer0000api.fda.gov
Kammerer Medical Systems GmbH & Co. KGStockach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Lincotek Trento S.P.ACire di Pergine Trento, ItalyContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Manufacturing Technology And Services, LLCOxford, AL, United StatesContract manufacturer0000api.fda.gov
Matrix Machining Technologies, Inc.Memphis, TN, United StatesContract manufacturer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medical GroupSAINT-PRIEST Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
MK medical GmbHEmmingen-Liptingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Machining Midtown LLCAtlanta, GA, United StatesContract manufacturer0000api.fda.gov
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, 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
Ortho Solutions UK LimitedMaldon Essex, United KingdomManufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paonan Biotech Co., LtdTaipei, TaiwanManufacturer0000api.fda.gov
Perryman CompanyHouston, PA, 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
Quintus, Inc.Camp Verde, AZ, United StatesContract manufacturer0000api.fda.gov
Rayco Steel Process, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Rudolf Storz GMBHEMMINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
SMT Schilling Metalltechnik GMBHMUHLHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Spinal Resources IncFort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Spitrex Orthopedics Switzerland SALe Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Starr Frame LLCRichardson, TX, United StatesSpecification developer0000api.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
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Polyvac SASWAMBRECHIES Nord, FranceContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Suzhou Ahno Medical Devices Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.Kunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, 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
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer0000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer0010api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaManufacturer0000api.fda.gov

Updated February 10, 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.