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
Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
Smith & Nephew, Inc.
Orthopedic
71d
Cleared
Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
Synthes (Usa)
Orthopedic
59d
Cleared
Jul 24, 1996
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
Synthes (Usa)
Orthopedic
57d
Cleared
Sep 12, 1994
HAIG NAIL
Howmedica Corp.
Orthopedic
207d
Cleared
Nov 23, 1992
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
Howmedica Corp.
Orthopedic
105d
Cleared
Feb 18, 1992
UNIVERSAL FEMORAL NAIL
Synthes (Usa)
Orthopedic
140d
Cleared
Feb 18, 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
Synthes (Usa)
Orthopedic
137d
Cleared
Jan 30, 1989
HUMERAL LOCKING NAIL SYSTEM
Howmedica Corp.
Orthopedic
139d
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