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
Aug 14, 2001
BAUMER LOCKING NAIL
Baumer, S.A
Orthopedic
90d
Cleared
Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic
76d
Cleared
Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic
75d
Cleared
Oct 30, 2000
WUJIN #3 TIBIAL NAIL
Biologically Oriented Prostheses
Orthopedic
90d
Cleared
Oct 06, 2000
SYNTHES PROXIMAL HUMERAL NAIL
Synthes (Usa)
Orthopedic
35d
Cleared
Apr 06, 2000
PEDIATRIC FIXATION RODS
Biomet, Inc.
Orthopedic
28d
Cleared
Oct 06, 1999
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
Howmedica Osteonics Corp.
Orthopedic
29d
Cleared
Sep 23, 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
Synthes (Usa)
Orthopedic
71d
Cleared
Aug 06, 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
Innervision, Inc.
Orthopedic
65d
Cleared
Jun 23, 1999
EUCLID REDUCTION AND GUIDANCE SYSTEM
Modular Cutting Systems, Inc.
Orthopedic
86d
Cleared
Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
Smith & Nephew, Inc.
Orthopedic
29d
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
Jul 12, 1995
BONE FIXATION NAIL
Acu Med, Inc.
Orthopedic
338d
Cleared
May 05, 1995
SMALL FRAGMENT PLATES AND SCREWS
Medpac
Orthopedic
44d
Cleared
Sep 12, 1994
HAIG NAIL
Howmedica Corp.
Orthopedic
207d
Cleared
Aug 25, 1993
FEMORAL INTRAMEDULLARY RODS
Applied Osteo Systems, Inc.
Orthopedic
244d
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
Nov 28, 1988
TRACER HIP PINNING SYSTEM
De Medica Mfg., Inc.
Orthopedic
40d
Cleared
May 30, 1984
POLY PLUG CEMENT RESTRICTOR
Latham Manufacturer
Orthopedic
131d