Data / Medical devices / Cerclage, Fixation
Cerclage, Fixation (JDQ): 97 FDA-registered makers in 11 countries
97 establishments in 11 countries are registered with the FDA to make Cerclage, Fixation (product code JDQ, Class 2, 21 CFR 888.3010). 33 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 130 510(k) clearances under this code, the latest on July 16, 2026, and lists 10 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JDQ
- Device class
- 2
- Regulation
- 888.3010
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 64 |
| Switzerland | 12 |
| Germany | 4 |
| France | 4 |
| Ireland | 3 |
| China | 3 |
| Malaysia | 3 |
| Brazil | 1 |
| Spain | 1 |
| Mexico | 1 |
| United Kingdom | 1 |
Makers of Cerclage, Fixation
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 |
|---|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 14 | June 21, 2018 | 0 | 2 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 10 | July 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Pioneer Surgical Technology, Inc. | Marquette, MI, United States | Contract manufacturer, Manufacturer | 7 | July 16, 2026 | 0 | 2 | 0 | api.fda.gov |
| Stryker Ireland Osteonics | County Cork, Ireland | Manufacturer | 7 | October 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Zimmer, Inc. | Warsaw, IN, United States | Contract manufacturer, Manufacturer | 4 | January 15, 2016 | 0 | 0 | 0 | api.fda.gov |
| Arthrex, Inc. | Naples, FL, United States | Specification developer | 3 | February 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 3 | May 12, 1993 | 0 | 0 | 0 | api.fda.gov |
| Acumed LLC | Hillsboro, OR, United States | Manufacturer | 2 | February 22, 1994 | 0 | 1 | 0 | api.fda.gov |
| Alto Development Corp. | Farmingdale, NJ, United States | Manufacturer, Specification developer | 2 | March 23, 2020 | 0 | 1 | 0 | api.fda.gov |
| Biomet, Inc. | Warsaw, IN, United States | Manufacturer | 2 | May 3, 2011 | 0 | 1 | 0 | api.fda.gov |
| Howmedica Osteonics Corp | Mahwah, NJ, United States | Manufacturer, Specification developer | 2 | October 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 2 | August 29, 2008 | 0 | 0 | 0 | api.fda.gov |
| Kinamed, Inc. | Camarillo, CA, United States | Manufacturer | 2 | August 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | March 13, 2024 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 2 | March 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aesculap AG | TUTTLINGEN, DONAU Baden-Wurttemberg, Germany | Manufacturer | 1 | December 27, 2006 | 0 | 0 | 0 | api.fda.gov |
| Circumfix Solutions, Inc | Collierville, TN, United States | Specification developer | 1 | January 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Depuy Orthopaedics, Inc. | Warsaw, IN, United States | Manufacturer, Specification developer | 1 | February 25, 1994 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | August 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 1 | August 4, 2023 | 0 | 0 | 0 | api.fda.gov |
| GM Dos Reis Industria E Comercio Ltda | Campinas Sao Paulo, Brazil | Manufacturer | 1 | August 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Implanet | Martillac Nouvelle-Aquitaine, France | Manufacturer | 1 | September 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| K2M, Inc. | Leesburg, VA, United States | Manufacturer, Specification developer | 1 | May 20, 2011 | 0 | 0 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 1 | April 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Manufacturer | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 1 | April 8, 1992 | 0 | 0 | 0 | api.fda.gov |
| Neos Surgery S.L. | Cerdanyola del Vallès Barcelona, Spain | Manufacturer | 1 | October 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 1 | July 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| STRYKER GmbH | SELZACH Solothurn, Switzerland | Manufacturer | 1 | December 30, 1991 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 1 | May 1, 2003 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 1 | July 28, 2011 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer, Repackager or relabeler | 1 | April 8, 1992 | 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 | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&W Swiss, Inc. | Clayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canwell Medical Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coulot Decolletage | CHATELLERAULT Vienne, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cousin Biotech | WERVICQ-SUD Nord, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, 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 | |
| Elite Medical, LLC | Bartlett, TN, 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 | |
| Engineered Medical Systems, LLC | Bartlett, 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 | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Galaz Science And Engineering S.S. De C.V. | Hermosillo Sonora, Mexico | 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 | |
| Hermann Medizintechnik GMBH | FRIDINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoosier, Inc. | Corona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Howmedica International S. De R.L. | LIMERICK Munster, Ireland | 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 | |
| Jabil Switzerland Manufacturing GmbH (Bettlach) | Bettlach Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Hagendorf) | Hagendorf Solothurn, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, 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 | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Solutions GMBH | Emmingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 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 | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Norwood Medical LLC | Dayton, OH, 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 | |
| Olive Branch Distribution Center | Olive Branch, MS, 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 | |
| Ortho Solutions UK Limited | Maldon Essex, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, 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 | |
| Precera Medical Herouville SAS | HEROUVILLE ST CLAIR CEDEX Normandie, France | 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 Medical Technologies | Warsaw, IN, 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 | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, 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 | |
| Samaplast AG | Sankt Margrethen Sankt Gallen, Switzerland | 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 | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Orthopaedics AG | AARAU Aargau, Switzerland | 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, Inc. - Manchester | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Anngrove | Cork Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 16, 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.