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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

CountryMakers
United States64
Switzerland12
Germany4
France4
Ireland3
China3
Malaysia3
Brazil1
Spain1
Mexico1
United Kingdom1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer14June 21, 2018020api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer10July 28, 2011000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, United StatesContract manufacturer, Manufacturer7July 16, 2026020api.fda.gov
Stryker Ireland OsteonicsCounty Cork, IrelandManufacturer7October 16, 2020000api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesContract manufacturer, Manufacturer4January 15, 2016000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer3February 20, 2025000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer3May 12, 1993000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer2February 22, 1994010api.fda.gov
Alto Development Corp.Farmingdale, NJ, United StatesManufacturer, Specification developer2March 23, 2020010api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer2May 3, 2011010api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer, Specification developer2October 16, 2020000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer2August 29, 2008000api.fda.gov
Kinamed, Inc.Camarillo, CA, United StatesManufacturer2August 1, 2018000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2March 13, 2024010api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer2March 13, 2024000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1December 27, 2006000api.fda.gov
Circumfix Solutions, IncCollierville, TN, United StatesSpecification developer1January 30, 2024000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer1February 25, 1994000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer1August 4, 2023000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1August 4, 2023000api.fda.gov
GM Dos Reis Industria E Comercio LtdaCampinas Sao Paulo, BrazilManufacturer1August 14, 2025000api.fda.gov
ImplanetMartillac Nouvelle-Aquitaine, FranceManufacturer1September 13, 2012000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer1May 20, 2011000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer1April 6, 2016000api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer1May 3, 2024000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer1May 3, 2024000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer1April 8, 1992000api.fda.gov
Neos Surgery S.L.Cerdanyola del Vallès Barcelona, SpainManufacturer1October 19, 2022000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1July 3, 2012000api.fda.gov
STRYKER GmbHSELZACH Solothurn, SwitzerlandManufacturer1December 30, 1991000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer1May 1, 2003000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1July 28, 2011000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler1April 8, 1992000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - WarsawWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesManufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
Canwell Medical Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.fda.gov
Coulot DecolletageCHATELLERAULT Vienne, FranceContract manufacturer0000api.fda.gov
Cousin BiotechWERVICQ-SUD Nord, FranceContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Eptam West LLCColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Fort Wayne Metals Research Products, LLCFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Galaz Science And Engineering S.S. De C.V.Hermosillo Sonora, MexicoContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hermann Medizintechnik GMBHFRIDINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Howmedica International S. De R.L.LIMERICK Munster, IrelandManufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)Mezzovico Ticino, SwitzerlandContract manufacturer0000api.fda.gov
KLS Martin SE & Co. KGMuhlheim/Donau Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Mahe Medical UsaLaramie, WY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Medcare Solutions GMBHEmmingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Norwood Medical LLCDayton, OH, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Ortho Solutions UK LimitedMaldon Essex, United KingdomManufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Praxis Powder Technology, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Precera Medical Herouville SASHEROUVILLE ST CLAIR CEDEX Normandie, FranceContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Samaplast AGSankt Margrethen Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
SCT, Inc.Franklin Lakes, NJ, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesManufacturer0000api.fda.gov
Smith & Nephew Orthopaedics AGAARAU Aargau, SwitzerlandManufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical, Inc. - ManchesterManchester, NH, United StatesContract manufacturer0000api.fda.gov
Stryker AnngroveCork Munster, IrelandContract manufacturer0000api.fda.gov
Suzhou Elite Precision Machinery Co., Ltd.Kunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
Zhejiang Biomet Medical Products Co., Ltd.Jinhua Zhejiang, ChinaContract manufacturer0000api.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.