FDA Product Code JDS: Nail, Fixation, Bone
FDA product code JDS covers bone fixation nails used in intramedullary and extramedullary fixation.
These implants provide axial stability across fracture sites and are used in the surgical treatment of long bone fractures, osteotomies, and fusions where nail-based fixation is preferred over plate or screw constructs.
JDS devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc. and Narang Medical , Ltd..
FDA 510(k) Cleared Nail, Fixation, Bone Devices (Product Code JDS)
About Product Code JDS - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code JDS since 1977, with 53 receiving FDA clearance (average review time: 96 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JDS have taken an average of 173 days to reach a decision - up from 91 days historically. Manufacturers should account for longer review timelines in current project planning.
JDS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →