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 Arthrex, Inc., Riverpoint Medical, LLC and Globus Medical, Inc..
FDA 510(k) Cleared Cerclage, Fixation Devices (Product Code JDQ)
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 Review Time
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 →