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., Synthes (Usa) and Howmedica Corp..
53
Total
53
Cleared
96d
Avg days
1977
Since
53 devices
Cleared
Oct 20, 1983
INTRAMEDULLARY BONE PLUG
Kirschner Medical Corp.
Orthopedic
97d
Cleared
May 02, 1980
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
Dow Corning Corp. Healthcare Industries Materials
Orthopedic
14d
Cleared
Feb 19, 1980
FUSON BONE PLUG, RADIOPAQUE
Zimmer, Inc.
Orthopedic
29d
Cleared
Feb 19, 1980
FEMORAL CEMENT RESTRICTOR
Biomet, Inc.
Orthopedic
29d
Cleared
Jan 26, 1977
B.G. FLEXIBLE NAIL SYSTEM
Howmedica Corp.
Orthopedic
5d