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Data / Medical devices / Fastener, Fixation, Nondegradable, Soft Tissue / United States

FDA-registered makers of Fastener, Fixation, Nondegradable, Soft Tissue in the United States: 117 establishments

117 establishments in the United States are registered with the FDA to make Fastener, Fixation, Nondegradable, Soft Tissue (product code MBI). 58 have a 510(k) clearance or PMA approval on file and 16 have a recall event. FDA data exported November 2, 2026.

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Device
Fastener, Fixation, Nondegradable, Soft Tissue
Product code
MBI
Country
United States

Makers of Fastener, Fixation, Nondegradable, Soft Tissue in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Arthrex, Inc.Naples, FL, United StatesManufacturer, Specification developer48June 26, 2026010api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer, Specification developer35July 9, 2026020api.fda.gov
Linvatec CorporationLargo, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer31May 13, 2026020api.fda.gov
DePuy Mitek, Inc.Raynham, MA, United StatesSpecification developer30October 6, 2023010api.fda.gov
Smith & Nephew Inc.Andover, MA, United StatesSpecification developer30July 9, 2026040api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer24March 5, 20200120api.fda.gov
Parcus Medical, L.L.C.Sarasota, FL, United StatesManufacturer23July 26, 2022000api.fda.gov
Riverpoint Medical LLCPortland, OR, United StatesComplaint file establishment, Contract manufacturer, Manufacturer20March 11, 2026010api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer, Repackager or relabeler18August 17, 2017000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Manufacturer, Specification developer17January 25, 2024050api.fda.gov
ArthroCare CorporationAustin, TX, United StatesSpecification developer12August 17, 2017010api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer12May 13, 2026010api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer12November 20, 2017000api.fda.gov
Cayenne Medical, Inc.Scottsdale, AZ, United StatesManufacturer10October 5, 2019000api.fda.gov
Paragon 28Englewood, CO, United StatesComplaint file establishment, Manufacturer, Specification developer10August 3, 2026010api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer, Manufacturer9August 30, 2018000api.fda.gov
Responsive ArthroscopyMinneapolis, MN, United StatesSpecification developer9October 14, 2025000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesComplaint file establishment, Specification developer9February 23, 2017000api.fda.gov
Tigon Medical LLCMillersville, MD, United StatesManufacturer, Specification developer6April 21, 2026000api.fda.gov
Aevumed, Inc.Malvern, PA, United StatesManufacturer5October 21, 2025000api.fda.gov
Dunamis Medical LLCGreenville, AL, United StatesManufacturer, Specification developer5February 14, 2020000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer5May 3, 2023000api.fda.gov
Rog Sports Medicine, Inc.Orland Park, IL, United StatesSpecification developer5December 15, 2011000api.fda.gov
Stryker EndoscopyGreenwood Village, CO, United StatesSpecification developer4November 20, 2017000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer4May 5, 2016010api.fda.gov
TORNIER Inc.Columbia City, IN, United StatesSpecification developer4April 4, 2014000api.fda.gov
Tornier, Inc.Bloomington, MN, United StatesComplaint file establishment, Manufacturer4April 4, 2014010api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer3May 20, 2014000api.fda.gov
Crossroads Extremity Systems LLCMemphis, TN, United StatesComplaint file establishment, Manufacturer3April 15, 2022000api.fda.gov
Iconn Orthopedics, LLCBirmingham, AL, United StatesComplaint file establishment, Manufacturer, Specification developer3October 19, 2018000api.fda.gov
Wright Medical Technology, Inc.Arlington, TN, United StatesManufacturer3July 30, 2014020api.fda.gov
Anika Therapeutics, Inc.Bedford, MA, United StatesSpecification developer2September 17, 2026000api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer2December 19, 2006000api.fda.gov
Fusion Orthopedics Usa, LLCMesa, AZ, United StatesComplaint file establishment, Specification developer2August 2, 2023000api.fda.gov
Medshape, Inc.Atlanta, GA, United StatesComplaint file establishment, Specification developer2March 7, 2013010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2January 23, 2013000api.fda.gov
TheramicroCordova, TN, United StatesRepackager or relabeler, Specification developer2March 6, 2026000api.fda.gov
Acuitive TechnologiesAllendale, NJ, United StatesManufacturer1September 20, 2023000api.fda.gov
ArtelonAtl, GA, United StatesManufacturer1September 2, 2020000api.fda.gov
Arthrex California Technology, IncorporatedSanta Barbara, CA, United StatesManufacturer1October 29, 2025000api.fda.gov
Arthrex Logistic CenterFort Myers, FL, United StatesManufacturer1December 21, 2012000api.fda.gov
ArthroTAK, LLCMissoula, MT, United StatesComplaint file establishment, Specification developer1May 1, 2026000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer1January 28, 2016000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer1January 28, 2016000api.fda.gov
Conextions IncSalt Lake City, UT, United StatesComplaint file establishment, Manufacturer1March 4, 2020000api.fda.gov
In2bones Usa, LLCCordova, TN, United StatesSpecification developer1August 20, 2020000api.fda.gov
Integrity Orthopaedics, Inc.Maple Plain, MN, United StatesManufacturer1January 26, 2023000api.fda.gov
International Life SciencesSandy Springs, GA, United StatesSpecification developer1September 2, 2020000api.fda.gov
Nvision Biomedical Technologies, IncSan Antonio, TX, United StatesRepackager or relabeler, Specification developer1November 10, 2020000api.fda.gov
Orthopediatrics, CorpWarsaw, IN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1June 20, 2013030api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesSpecification developer1June 20, 2013000api.fda.gov
Precision Medical TechnologiesRome City, IN, United StatesSpecification developer1June 20, 2013000api.fda.gov
Simparo, IncMobile, AL, United StatesSpecification developer1February 4, 2023000api.fda.gov
Skeletal Dynamics, IncMiami, FL, United StatesComplaint file establishment, Specification developer1July 19, 2024000api.fda.gov
Subchondral SolutionsCosta Mesa, CA, United StatesComplaint file establishment, Specification developer1July 29, 2022000api.fda.gov
Suture Tech, Inc.Durham, NC, United StatesComplaint file establishment, Specification developer1September 5, 2025000api.fda.gov
SportCareHidalgo, TX, United StatesSpecification developer1August 2, 2024000api.fda.gov
The Orthopaedic Implant CompanyReno, NV, United StatesSpecification developer1December 28, 2018000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Avalign Integrated Medical Solutions, IncMentor, OH, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Aptyx - CharlotteCharlotte, NC, United StatesContract manufacturer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer0000api.fda.gov
Cortland Company IncCortland, NY, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Eca Medical InstrumentsNewbury Park, CA, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Fort Wayne Metals Research Products, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Genesis Medical Plastics Ltd. Co.Cypress, TX, United StatesContract manufacturer0000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer0000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Janco, Inc.Rollinsford, NH, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Lifenet HealthVirginia Beach, VA, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthVirginia Bch, VA, United StatesContract manufacturer0000api.fda.gov
LifeNet HealthPlainfield, IN, United StatesContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medical Device And Implants LLCLancaster, PA, 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
Moebius Precision CorpLansing, MI, United StatesContract manufacturer0000api.fda.gov
Mount MFGMarquette, MI, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Novus Manufacturing SolutionsMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Phoenix Medical Products, Inc.Mountain City, TN, United StatesContract manufacturer0000api.fda.gov
Praxis Powder Technology, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Performance Fibers OEM LLCMansfield, MA, 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
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.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
Surgical Instrument Manufacturers, LLCFenton, MO, 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
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Threadstone LLCMillersville, MD, United StatesContract manufacturer0000api.fda.gov
Trilliant Surgical LLCHouston, TX, United StatesContract manufacturer0000api.fda.gov
Viant Medical, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Viant San Antonio, Inc.San Antonio, TX, United StatesContract manufacturer0000api.fda.gov
Ziptek LLCSarasota, FL, United StatesSpecification 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.