Data / Medical devices / Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component / United States
FDA-registered makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component in the United States: 122 establishments
122 establishments in the United States are registered with the FDA to make Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (product code KTT). 41 have a 510(k) clearance or PMA approval on file and 9 have a recall event. FDA data exported November 3, 2026.
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- Device
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Product code
- KTT
- Country
- United States
Makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 53 | December 15, 2011 | 0 | 4 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 40 | June 11, 2026 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 17 | July 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 17 | July 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 14 | December 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 14 | June 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 13 | June 6, 2018 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions Phoenix | Phoenix, AZ, United States | Reprocessor | 11 | January 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Specification developer | 10 | January 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 10 | December 30, 2015 | 0 | 4 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 9 | August 8, 2025 | 0 | 0 | 0 | api.fda.gov |
| Paragon 28 | Englewood, CO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 7 | December 19, 2025 | 0 | 0 | 0 | api.fda.gov |
| Orthopediatrics, Corp | Warsaw, IN, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 6 | March 7, 2025 | 0 | 1 | 0 | api.fda.gov |
| Sterilmed, Inc. | Plymouth, MN, United States | Reprocessor, Specification developer | 5 | November 10, 2016 | 0 | 0 | 0 | api.fda.gov |
| Vilex LLC | Mcminnville, TN, United States | Manufacturer, Repackager or relabeler | 5 | April 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| JMG Machine, Inc. | La Mirada, CA, United States | Contract manufacturer, Manufacturer | 4 | December 15, 2011 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 4 | July 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medshape, Inc. | Atlanta, GA, United States | Complaint file establishment, Specification developer | 3 | February 16, 2016 | 0 | 1 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 2 | April 15, 1986 | 0 | 1 | 0 | api.fda.gov |
| Fusion Orthopedics Usa, LLC | Mesa, AZ, United States | Complaint file establishment, Specification developer | 2 | May 30, 2024 | 0 | 3 | 0 | api.fda.gov |
| GLW, Inc. | Englewood Cliffs, NJ, United States | Complaint file establishment, Specification developer | 2 | September 14, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 2 | July 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| NUTEK Orthopaedics, Inc | Fort Lauderdale, FL, United States | Specification developer | 2 | May 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Manufacturer | 2 | December 30, 2015 | 0 | 0 | 0 | api.fda.gov |
| Response Ortho Solutions LLC | Boynton Beach, FL, United States | Manufacturer | 2 | November 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| The Orthopaedic Implant Company | Reno, NV, United States | Specification developer | 2 | September 27, 2017 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 1 | September 17, 2010 | 0 | 0 | 0 | api.fda.gov |
| Blueocean Global Corp | Southold, NY, United States | Specification developer | 1 | January 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Extremity Medical, LLC | Parsippany, NJ, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | May 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | January 12, 2018 | 0 | 0 | 0 | api.fda.gov |
| Kinamed, Inc. | Camarillo, CA, United States | Manufacturer | 1 | November 9, 2007 | 0 | 1 | 0 | api.fda.gov |
| Kyocera Medical Technologies, Inc. | Redlands, CA, United States | Complaint file establishment, Specification developer | 1 | May 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 1 | September 7, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medusa Orthopedics, LLC | Fleetwood, PA, United States | Manufacturer | 1 | November 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Metric Medical Devices, Inc. | Helotes, TX, United States | Manufacturer | 1 | May 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 1 | November 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| NuVasive Specialized Orthopedics, Inc. | Audubon, PA, United States | Manufacturer | 1 | November 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Orthonovis, Inc. | Palm Coast, FL, United States | Manufacturer, Specification developer | 1 | August 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sequel Medical Inc. | Fort Lauderdale, FL, United States | Specification developer | 1 | January 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| SIGN Fracture Care International | Richland, WA, United States | Manufacturer | 1 | August 26, 2009 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Manufacturing B.V. | Mercedita, PR, United States | Manufacturer | 1 | May 1, 2015 | 0 | 2 | 0 | api.fda.gov |
| 3D MEDICAL MANUFACTURING, INC. (dba Tecomet) | Riviera Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advanced Concept Innovations LLC | Lakeland, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alden Tool Company, Inc. | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Elmhurst | Elmhurst, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Warsaw | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex Manufacturing Inc. | Pendleton, SC, United States | Contract manufacturer, Contract sterilizer | 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 | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Delivery Systems Division | Greenwood, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & J Medical LLC | Kendallville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Banister Tool, Inc. | Pflugerville, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BioDynamik | Lake Forest, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Criterion Tool & Die Inc DBA Criterion Precision Machining | Brookpark, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam West LLC | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Five Star Manufacturing, Inc. | New Bedford, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gauthier Biomedical, Inc. | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| General Machine, Inc. | Colorado Springs, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardian Medical Usa, Inc | Swanton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huron Tool & Cutter Grinding | Farmingdale, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mackay Manufacturing, Inc. | Spokane Valley, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maitland Engineering | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Matrix Machining Technologies, Inc. | Memphis, TN, 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 | |
| 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 | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, 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 | |
| Machining Midtown LLC | Atlanta, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maestro Logistics, LLC | Austin, TX, 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 | |
| New Paradigm Biomedical, LLC | Dorchester, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nypro Inc (Maple Grove) | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Odyssey Medical Technologies, LLC | Bartlett, TN, 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 | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OsteoCentric Technologies,Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Forms, Inc. | Butler, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies | Rome City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision One Medical | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulse Technologies, Inc. | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Castleton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision One Medical | Hoover, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qualitex Ne LLC | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quintus, Inc. | Camp Verde, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rayco Steel Process, Inc. | Warsaw, IN, 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 | |
| SCT, Inc. | Franklin Lakes, NJ, 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 | |
| Symmetry Medical Manufacturing Inc | Claypool, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Symmetry Medical Manufacturing Inc. | Warsaw, IN, 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 | |
| TORNIER Inc. | Columbia City, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tornier, Inc. | Bloomington, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Triangle Manufacturing Co., Inc. | Upper Saddle River, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, 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 | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, LLC | Fort Wayne, IN, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.