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 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 Sep 12, 1994
HAIG NAIL
K940736
Howmedica Corp.
Orthopedic · 207d
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 Oct 20, 1983
INTRAMEDULLARY BONE PLUG
K832328
Kirschner Medical Corp.
Orthopedic · 97d
Cleared May 02, 1980
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
K800898
Dow Corning Corp. Healthcare Industries Materials
Orthopedic · 14d
Cleared Feb 19, 1980
FUSON BONE PLUG, RADIOPAQUE
K800142
Zimmer, Inc.
Orthopedic · 29d
Cleared Feb 19, 1980
FEMORAL CEMENT RESTRICTOR
K800144
Biomet, Inc.
Orthopedic · 29d
Cleared Jan 26, 1977
B.G. FLEXIBLE NAIL SYSTEM
K770130
Howmedica Corp.
Orthopedic · 5d