Data / Medical devices / Component, Traction, Invasive
Component, Traction, Invasive (JEC): 43 FDA-registered makers in 7 countries
43 establishments in 7 countries are registered with the FDA to make Component, Traction, Invasive (product code JEC, Class 2, 21 CFR 888.3040). 19 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 85 510(k) clearances under this code, the latest on April 23, 2021, and lists 6 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JEC
- Device class
- 2
- Regulation
- 888.3040
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 25 |
| Switzerland | 8 |
| Germany | 3 |
| Malaysia | 3 |
| France | 2 |
| Canada | 1 |
| Italy | 1 |
Makers of Component, Traction, Invasive
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Manufacturer | 12 | January 14, 2011 | 0 | 1 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 7 | June 16, 1994 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 4 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 3 | February 19, 1997 | 0 | 1 | 0 | api.fda.gov |
| Hand Biomechanics Lab, Inc. | Sacramento, CA, United States | Manufacturer | 3 | October 22, 2018 | 0 | 1 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Specification developer | 2 | January 11, 1990 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 2 | December 15, 1999 | 0 | 0 | 0 | api.fda.gov |
| G-5 Florida LLC | Jax, FL, United States | Manufacturer | 2 | March 2, 2020 | 0 | 1 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 2 | December 15, 1999 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Repackager or relabeler, Specification developer | 2 | April 4, 1995 | 0 | 0 | 0 | api.fda.gov |
| Virak Orthopedics LLC | Madison, NJ, United States | Repackager or relabeler, Specification developer | 2 | October 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Arbutus Medical, Inc | Burnaby British Columbia, Canada | Manufacturer | 1 | April 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Biomet France | Valence Drome, France | Manufacturer | 1 | November 21, 1991 | 0 | 0 | 0 | api.fda.gov |
| JMG Machine, Inc. | La Mirada, CA, United States | Contract manufacturer, Manufacturer | 1 | February 22, 1994 | 0 | 0 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 1 | August 25, 2004 | 0 | 0 | 0 | api.fda.gov |
| Medline ReNewal | Redmond, OR, United States | Reprocessor | 1 | December 28, 2016 | 0 | 0 | 0 | api.fda.gov |
| Orthofix SRL | BUSSOLENGO Verona, Italy | Manufacturer | 1 | April 4, 1995 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Advanced Concept Innovations LLC | Lakeland, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Composites Busch SA | Porrentruy Jura, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CREATEC GmbH & CO. KG | FRIEDRICHSHAFEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HN And M GMBH | Derendingen Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HPC Medx | Hanover, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Bettlach) | Bettlach Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | 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 | |
| NUTEK Orthopaedics, Inc | Fort Lauderdale, FL, United States | Specification developer | 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 | |
| Spitrex Orthopedics Switzerland SA | Le Locle Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Perai Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Straits Orthopaedics (MFG) Sdn Bhd | Bandar Cassia Pulau Pinang, Malaysia | 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 | |
| Symmetry Medical Polyvac SAS | WAMBRECHIES Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions | Tempe, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Sustainability Solutions Phoenix | Phoenix, AZ, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wright Medical Technology, Inc. | Arlington, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 23, 2021. 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.