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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arthrex, Inc. | Naples, FL, United States | Manufacturer, Specification developer | 48 | June 26, 2026 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Mansfield, MA, United States | Manufacturer, Specification developer | 35 | July 9, 2026 | 0 | 2 | 0 | api.fda.gov |
| Linvatec Corporation | Largo, FL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 31 | May 13, 2026 | 0 | 2 | 0 | api.fda.gov |
| DePuy Mitek, Inc. | Raynham, MA, United States | Specification developer | 30 | October 6, 2023 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Andover, MA, United States | Specification developer | 30 | July 9, 2026 | 0 | 4 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 24 | March 5, 2020 | 0 | 12 | 0 | api.fda.gov |
| Parcus Medical, L.L.C. | Sarasota, FL, United States | Manufacturer | 23 | July 26, 2022 | 0 | 0 | 0 | api.fda.gov |
| Riverpoint Medical LLC | Portland, OR, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 20 | March 11, 2026 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer, Repackager or relabeler | 18 | August 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 17 | January 25, 2024 | 0 | 5 | 0 | api.fda.gov |
| ArthroCare Corporation | Austin, TX, United States | Specification developer | 12 | August 17, 2017 | 0 | 1 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 12 | May 13, 2026 | 0 | 1 | 0 | api.fda.gov |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Contract manufacturer, Manufacturer | 12 | November 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| Cayenne Medical, Inc. | Scottsdale, AZ, United States | Manufacturer | 10 | October 5, 2019 | 0 | 0 | 0 | api.fda.gov |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | August 3, 2026 | 0 | 1 | 0 | api.fda.gov |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer, Manufacturer | 9 | August 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Responsive Arthroscopy | Minneapolis, MN, United States | Specification developer | 9 | October 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 9 | February 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Tigon Medical LLC | Millersville, MD, United States | Manufacturer, Specification developer | 6 | April 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Aevumed, Inc. | Malvern, PA, United States | Manufacturer | 5 | October 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Dunamis Medical LLC | Greenville, AL, United States | Manufacturer, Specification developer | 5 | February 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 5 | May 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Rog Sports Medicine, Inc. | Orland Park, IL, United States | Specification developer | 5 | December 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Stryker Endoscopy | Greenwood Village, CO, United States | Specification developer | 4 | November 20, 2017 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 4 | May 5, 2016 | 0 | 1 | 0 | api.fda.gov |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 4 | April 4, 2014 | 0 | 0 | 0 | api.fda.gov |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 4 | April 4, 2014 | 0 | 1 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 3 | May 20, 2014 | 0 | 0 | 0 | api.fda.gov |
| Crossroads Extremity Systems LLC | Memphis, TN, United States | Complaint file establishment, Manufacturer | 3 | April 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Iconn Orthopedics, LLC | Birmingham, AL, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | October 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 3 | July 30, 2014 | 0 | 2 | 0 | api.fda.gov |
| Anika Therapeutics, Inc. | Bedford, MA, United States | Specification developer | 2 | September 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer | 2 | December 19, 2006 | 0 | 0 | 0 | api.fda.gov |
| Fusion Orthopedics Usa, LLC | Mesa, AZ, United States | Complaint file establishment, Specification developer | 2 | August 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medshape, Inc. | Atlanta, GA, United States | Complaint file establishment, Specification developer | 2 | March 7, 2013 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | January 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Theramicro | Cordova, TN, United States | Repackager or relabeler, Specification developer | 2 | March 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Acuitive Technologies | Allendale, NJ, United States | Manufacturer | 1 | September 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Artelon | Atl, GA, United States | Manufacturer | 1 | September 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Arthrex California Technology, Incorporated | Santa Barbara, CA, United States | Manufacturer | 1 | October 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Arthrex Logistic Center | Fort Myers, FL, United States | Manufacturer | 1 | December 21, 2012 | 0 | 0 | 0 | api.fda.gov |
| ArthroTAK, LLC | Missoula, MT, United States | Complaint file establishment, Specification developer | 1 | May 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Rochester, NY, United States | Complaint file establishment, Specification developer | 1 | January 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Manufacturer | 1 | January 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| Conextions Inc | Salt Lake City, UT, United States | Complaint file establishment, Manufacturer | 1 | March 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| In2bones Usa, LLC | Cordova, TN, United States | Specification developer | 1 | August 20, 2020 | 0 | 0 | 0 | api.fda.gov |
| Integrity Orthopaedics, Inc. | Maple Plain, MN, United States | Manufacturer | 1 | January 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| International Life Sciences | Sandy Springs, GA, United States | Specification developer | 1 | September 2, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nvision Biomedical Technologies, Inc | San Antonio, TX, United States | Repackager or relabeler, Specification developer | 1 | November 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | June 20, 2013 | 0 | 3 | 0 | api.fda.gov |
| Precision Medical Technologies | Warsaw, IN, United States | Specification developer | 1 | June 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Precision Medical Technologies | Rome City, IN, United States | Specification developer | 1 | June 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Simparo, Inc | Mobile, AL, United States | Specification developer | 1 | February 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Skeletal Dynamics, Inc | Miami, FL, United States | Complaint file establishment, Specification developer | 1 | July 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Subchondral Solutions | Costa Mesa, CA, United States | Complaint file establishment, Specification developer | 1 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Suture Tech, Inc. | Durham, NC, United States | Complaint file establishment, Specification developer | 1 | September 5, 2025 | 0 | 0 | 0 | api.fda.gov |
| SportCare | Hidalgo, TX, United States | Specification developer | 1 | August 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| The Orthopaedic Implant Company | Reno, NV, United States | Specification developer | 1 | December 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Integrated Medical Solutions, Inc | Mentor, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aptyx - Charlotte | Charlotte, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Ave Maria, FL, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boulder Biomed LLC | Boulder, CO, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Wire Cut Company, Inc. | Valencia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cortland Company Inc | Cortland, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Design Standards Corp. | Charlestown, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eca Medical Instruments | Newbury Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fort Wayne Metals Research Products, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Genesis Medical Plastics Ltd. Co. | Cypress, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Janco, Inc. | Rollinsford, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Outsourcing, Inc. | Brea, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifenet Health | Virginia Beach, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Virginia Bch, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeNet Health | Plainfield, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Device And Implants LLC | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech LLC | Millington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moebius Precision Corp | Lansing, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount MFG | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novus Manufacturing Solutions | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices LLC | Rochester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Medical LLC | Memphis, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Unique | Bridgeport, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Medical Products, Inc. | Mountain City, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Praxis Powder Technology, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRO-TECH Design & Mfg, Inc. | Arlington, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Performance Fibers OEM LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R.K. Manufacturing | Danbury, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resonetics, LLC | Bethel, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seaway Plastics Engineering, LLC | Brooksville, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spectrum Plastics Group | Saint Louis Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tesco Associates, Inc. | Tyngsboro, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Threadstone LLC | Millersville, MD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trilliant Surgical LLC | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant San Antonio, Inc. | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziptek LLC | Sarasota, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.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.