JDQ · Cerclage, Fixation
Orthopedic · 21 CFR 888.3010 · Class 2
Overview
| Product Code | JDQ |
|---|---|
| Device Name | Cerclage, Fixation |
| Regulation | 21 CFR 888.3010 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| 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 | Stitch Cerclage Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | Aug 14, 2025 | SESE |
| K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures | Arthrex, Inc. | Feb 20, 2025 | SESE |
| K232733 | Mbrace Cable | Medacta International S.A. | May 3, 2024 | SESE |
| K233949 | ACCORD Cable System | Smith & Nephew, Inc. | Mar 13, 2024 | SESE |
| K232986 | VariTrax Sternal CircumFixation System | Circumfix Solutions, Inc. | Jan 30, 2024 | SESE |
| K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | Aug 24, 2023 | SESE |
| K231333 | STRETTO Cable System | Globus Medical, Inc. | Aug 4, 2023 | SESE |
| K220765 | HS Fiber Cerclage | Riverpoint Medical, LLC | Jul 26, 2023 | SESE |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | Oct 19, 2022 | SESE |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | Jan 19, 2022 | SESE |
| K201497 | EVOS Cabling System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Oct 28, 2020 | SESE |
| K202016 | Dall-Miles® Cable System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 16, 2020 | SESE |
| K193479 | Sternal Cable System | A & E Medical Corporation | Mar 23, 2020 | SESE |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | Mar 12, 2020 | SESE |
| K181607 | Thorecon Rigid Fixation System | A & E Medical Corporation | Oct 12, 2018 | SESE |
| K173910 | Impress SFS System | Cable Fix Medical, LLC | Sep 14, 2018 | SESE |
| K181749 | SuperCable® Iso-Elastic Cerclage System | Kinamed, Incorporated | Aug 1, 2018 | SESE |
| K172975 | 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 | Sternal Cable System | A & E Medical Corporation | May 31, 2018 | SESE |
| K173579 | 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
