FDA Product Code JDQ: Cerclage, Fixation
FDA product code JDQ covers cerclage fixation devices used to encircle and compress bone.
These cable, wire, or band systems are looped around bone to provide circumferential compression and stability in periprosthetic fractures, femoral fractures, and osteotomy fixation. They are used as adjuncts to intramedullary nails and plates when the bone cannot accept standard screw fixation.
JDQ devices are Class II medical devices, regulated under 21 CFR 888.3010 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Synthes (Usa), Howmedica Corp. and A & E Medical Corporation.
129
Total
129
Cleared
132d
Avg days
1984
Since
Declining activity -
2 submissions in the last 2 years
vs 7 in the prior period
Review times increasing: avg
178d
recently vs 131d historically
FDA 510(k) Cleared Cerclage, Fixation Devices (Product Code JDQ)
129 devices
Cleared
Aug 14, 2025
Stitch Cerclage – Suture Tapes
GM Dos Reis Industria e Comercio Ltda.
Orthopedic
238d
Cleared
Feb 20, 2025
Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex, Inc.
Orthopedic
118d
Cleared
May 03, 2024
Mbrace Cable
Medacta International S.A.
Orthopedic
239d
Cleared
Mar 13, 2024
ACCORD Cable System
Smith & Nephew, Inc.
Orthopedic
90d
Cleared
Jan 30, 2024
VariTrax Sternal CircumFixation System
Circumfix Solutions, Inc.
Orthopedic
130d
Cleared
Aug 24, 2023
Arthrex Radiopaque FiberTape Cerclage sutures
Arthrex, Inc.
Orthopedic
141d
Cleared
Aug 04, 2023
STRETTO™ Cable System
Globus Medical, Inc.
Orthopedic
88d
Cleared
Jul 26, 2023
HS Fiber Cerclage
Riverpoint Medical, LLC
Orthopedic
497d
Cleared
Oct 19, 2022
STERN FIX Sternal Stabilization System
Neos Surgery S.L
Orthopedic
120d
Cleared
Jan 19, 2022
Stern Fix Sternal Stabilization System
Neos Surgery S.L
Orthopedic
238d
Cleared
Oct 28, 2020
EVOS Cabling System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic
145d
Cleared
Oct 16, 2020
Dall-Miles® Cable System
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
87d
Cleared
Mar 23, 2020
Sternal Cable System
A & E Medical Corporation
Orthopedic
98d
Cleared
Mar 12, 2020
Tritium Sternal Cable Plate System
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
Orthopedic
87d
Cleared
Oct 12, 2018
Thorecon Rigid Fixation System
A & E Medical Corporation
Orthopedic
115d
Cleared
Sep 14, 2018
Impress SFS System
Cable Fix Medical, LLC
Orthopedic
266d
Cleared
Aug 01, 2018
SuperCable® Iso-Elastic™ Cerclage System
Kinamed, Incorporated
Orthopedic
30d
Cleared
Jun 21, 2018
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.
Orthopedic
267d
Cleared
May 31, 2018
Sternal Cable System
A & E Medical Corporation
Orthopedic
87d
Cleared
Feb 12, 2018
Thorecon™ Fixation System
A & E Medical Corporation
Orthopedic
84d
Cleared
Nov 15, 2017
Arthrex FiberTape Cerclage
Arthrex, Inc.
Orthopedic
295d
Cleared
Jan 15, 2016
Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
Zimmer, Inc.
Orthopedic
192d
Cleared
Jul 01, 2015
Suture Wires and Wire Loops
Zimmer, Inc.
Orthopedic
90d
Cleared
Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
Biomet, Inc.
Orthopedic
88d
About Product Code JDQ - Regulatory Context
510(k) Submission Activity
129 total 510(k) submissions under product code JDQ since 1984, with 129 receiving FDA clearance (average review time: 132 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 7 in the prior period.
FDA 510(k) Review Time - JDQ Product Code
Recent submissions under JDQ have taken an average of 178 days to reach a decision - up from 131 days historically. Manufacturers should account for longer review timelines in current project planning.
JDQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →