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/productcode/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](/device/K243905.md) | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | Aug 14, 2025 | SESE |
| [K243344](/device/K243344.md) | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | Feb 20, 2025 | SESE |
| [K232733](/device/K232733.md) | Mbrace Cable | Medacta International S.A. | May 3, 2024 | SESE |
| [K233949](/device/K233949.md) | ACCORD Cable System | Smith & Nephew, Inc. | Mar 13, 2024 | SESE |
| [K232986](/device/K232986.md) | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | Jan 30, 2024 | SESE |
| [K230976](/device/K230976.md) | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | Aug 24, 2023 | SESE |
| [K231333](/device/K231333.md) | STRETTO™ Cable System | Globus Medical, Inc. | Aug 4, 2023 | SESE |
| [K220765](/device/K220765.md) | HS Fiber Cerclage | Riverpoint Medical, LLC | Jul 26, 2023 | SESE |
| [K221795](/device/K221795.md) | STERN FIX Sternal Stabilization System | Neos Surgery S.L | Oct 19, 2022 | SESE |
| [K211613](/device/K211613.md) | Stern Fix Sternal Stabilization System | Neos Surgery S.L | Jan 19, 2022 | SESE |
| [K201497](/device/K201497.md) | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Oct 28, 2020 | SESE |
| [K202016](/device/K202016.md) | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 16, 2020 | SESE |
| [K193479](/device/K193479.md) | Sternal Cable System | A & E Medical Corporation | Mar 23, 2020 | SESE |
| [K193468](/device/K193468.md) | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Mar 12, 2020 | SESE |
| [K181607](/device/K181607.md) | Thorecon Rigid Fixation System | A & E Medical Corporation | Oct 12, 2018 | SESE |
| [K173910](/device/K173910.md) | Impress SFS System | Cable Fix Medical, LLC | Sep 14, 2018 | SESE |
| [K181749](/device/K181749.md) | SuperCable® Iso-Elastic™ Cerclage System | Kinamed, Incorporated | Aug 1, 2018 | SESE |
| [K172975](/device/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](/device/K180582.md) | Sternal Cable System | A & E Medical Corporation | May 31, 2018 | SESE |
| [K173579](/device/K173579.md) | Thorecon™ Fixation System | A & E Medical Corporation | Feb 12, 2018 | SESE |

## Top Applicants

- Pioneer Surgical Technology — 11 clearances
- Howmedica Corp. — 8 clearances
- Synthes (Usa) — 8 clearances
- A & E Medical Corporation — 4 clearances
- Arthrex, Inc. — 3 clearances

---

**Source:** [https://fda.innolitics.com/productcode/JDQ](https://fda.innolitics.com/productcode/JDQ)

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