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., Synthes (Usa) and Howmedica Corp..

53
Total
53
Cleared
96d
Avg days
1977
Since
53 devices
25–48 of 53
Cleared Aug 14, 2001
BAUMER LOCKING NAIL
K011504
Baumer, S.A
Orthopedic · 90d
Cleared Dec 28, 2000
FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003212
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 76d
Cleared Dec 27, 2000
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
K003215
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 75d
Cleared Oct 30, 2000
WUJIN #3 TIBIAL NAIL
K002325
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Oct 06, 2000
SYNTHES PROXIMAL HUMERAL NAIL
K002729
Synthes (Usa)
Orthopedic · 35d
Cleared Apr 06, 2000
PEDIATRIC FIXATION RODS
K000764
Biomet, Inc.
Orthopedic · 28d
Cleared Oct 06, 1999
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Sep 23, 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348
Synthes (Usa)
Orthopedic · 71d
Cleared Aug 06, 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K991877
Innervision, Inc.
Orthopedic · 65d
Cleared Jun 23, 1999
EUCLID REDUCTION AND GUIDANCE SYSTEM
K991037
Modular Cutting Systems, Inc.
Orthopedic · 86d
Cleared Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
K983942
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Sep 04, 1997
SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM
K972516
Synthes (Usa)
Orthopedic · 59d
Cleared Jul 24, 1996
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
K962047
Synthes (Usa)
Orthopedic · 57d
Cleared Jul 12, 1995
BONE FIXATION NAIL
K943855
Acu Med, Inc.
Orthopedic · 338d
Cleared May 05, 1995
SMALL FRAGMENT PLATES AND SCREWS
K951302
Medpac
Orthopedic · 44d
Cleared Sep 12, 1994
HAIG NAIL
K940736
Howmedica Corp.
Orthopedic · 207d
Cleared Aug 25, 1993
FEMORAL INTRAMEDULLARY RODS
K926465
Applied Osteo Systems, Inc.
Orthopedic · 244d
Cleared Nov 23, 1992
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
K924004
Howmedica Corp.
Orthopedic · 105d
Cleared Feb 18, 1992
UNIVERSAL FEMORAL NAIL
K914371
Synthes (Usa)
Orthopedic · 140d
Cleared Feb 18, 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453
Synthes (Usa)
Orthopedic · 137d
Cleared Jan 30, 1989
HUMERAL LOCKING NAIL SYSTEM
K883882
Howmedica Corp.
Orthopedic · 139d
Cleared Nov 28, 1988
TRACER HIP PINNING SYSTEM
K884406
De Medica Mfg., Inc.
Orthopedic · 40d
Cleared May 30, 1984
POLY PLUG CEMENT RESTRICTOR
K840242
Latham Manufacturer
Orthopedic · 131d