JDS · Class II · 21 CFR 888.3030

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..

4
Total
4
Cleared
151d
Avg days
2023
Since

List of Nail, Fixation, Bone devices cleared through 510(k)

4 devices
1–4 of 4
Cleared Jun 12, 2025
TRIGEN Stable Lock Nut & Washer
K243608
Smith & Nephew, Inc.
Orthopedic · 202d
Cleared Sep 20, 2024
TRIGEN MAX Tibial Nail System
K240061
Smith & Nephew, Inc.
Orthopedic · 255d
Cleared Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
K241804
Smith & Nephew, Inc.
Orthopedic · 62d
Cleared Jun 14, 2023
TRIGEN META-NAIL Nail System
K230761
Smith & Nephew, Inc.
Orthopedic · 86d

How to use this database

This page lists all FDA 510(k) submissions for Nail, Fixation, Bone devices (product code JDS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →