Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3010](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3010) → JDQ — Cerclage, Fixation # JDQ · Cerclage, Fixation _Orthopedic · 21 CFR 888.3010 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ ## Overview - **Product Code:** JDQ - **Device Name:** Cerclage, Fixation - **Regulation:** [21 CFR 888.3010](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3010) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **Implant:** yes ## Identification A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 129) Showing 20 most recent of 129 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K243905](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K243905.md) | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | Aug 14, 2025 | SESE | | [K243344](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K243344.md) | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | Feb 20, 2025 | SESE | | [K232733](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K232733.md) | Mbrace Cable | Medacta International S.A. | May 3, 2024 | SESE | | [K233949](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K233949.md) | ACCORD Cable System | Smith & Nephew, Inc. | Mar 13, 2024 | SESE | | [K232986](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K232986.md) | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | Jan 30, 2024 | SESE | | [K230976](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K230976.md) | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | Aug 24, 2023 | SESE | | [K231333](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K231333.md) | STRETTO™ Cable System | Globus Medical, Inc. | Aug 4, 2023 | SESE | | [K220765](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K220765.md) | HS Fiber Cerclage | Riverpoint Medical, LLC | Jul 26, 2023 | SESE | | [K221795](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K221795.md) | STERN FIX Sternal Stabilization System | Neos Surgery S.L | Oct 19, 2022 | SESE | | [K211613](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K211613.md) | Stern Fix Sternal Stabilization System | Neos Surgery S.L | Jan 19, 2022 | SESE | | [K201497](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K201497.md) | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Oct 28, 2020 | SESE | | [K202016](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K202016.md) | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 16, 2020 | SESE | | [K193479](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K193479.md) | Sternal Cable System | A & E Medical Corporation | Mar 23, 2020 | SESE | | [K193468](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K193468.md) | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Mar 12, 2020 | SESE | | [K181607](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K181607.md) | Thorecon Rigid Fixation System | A & E Medical Corporation | Oct 12, 2018 | SESE | | [K173910](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K173910.md) | Impress SFS System | Cable Fix Medical, LLC | Sep 14, 2018 | SESE | | [K181749](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K181749.md) | SuperCable® Iso-Elastic™ Cerclage System | Kinamed, Incorporated | Aug 1, 2018 | SESE | | [K172975](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K172975.md) | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | Jun 21, 2018 | SESE | | [K180582](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K180582.md) | Sternal Cable System | A & E Medical Corporation | May 31, 2018 | SESE | | [K173579](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ/K173579.md) | Thorecon™ Fixation System | A & E Medical Corporation | Feb 12, 2018 | SESE | ## Top Applicants - Pioneer Surgical Technology — 11 clearances - Synthes (Usa) — 8 clearances - Howmedica Corp. — 8 clearances - A & E Medical Corporation — 4 clearances - Smith & Nephew, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JDQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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