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
Growing category -
3 submissions in the last 2 years
vs 2 in the prior period
Review times increasing: avg
173d
recently vs 91d historically
FDA 510(k) Cleared Nail, Fixation, Bone Devices (Product Code JDS)
53 devices
Cleared
Jun 12, 2025
TRIGEN Stable Lock Nut & Washer
Smith & Nephew, Inc.
Orthopedic
202d
Cleared
Sep 20, 2024
TRIGEN MAX Tibial Nail System
Smith & Nephew, Inc.
Orthopedic
255d
Cleared
Aug 22, 2024
TRIGEN INTERTAN 10S Nail System
Smith & Nephew, Inc.
Orthopedic
62d
Cleared
Feb 20, 2024
NET BRAND Osteosynthesis Nailing System
Narang Medical , Ltd.
Orthopedic
146d
Cleared
Jun 14, 2023
TRIGEN META-NAIL Nail System
Smith & Nephew, Inc.
Orthopedic
86d
Cleared
Sep 03, 2020
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
Synthes USA Products, LLC
Orthopedic
106d
Cleared
Jun 10, 2020
Auxein Nailing System
Auxein Medical Private Limited
Orthopedic
320d
Cleared
Feb 20, 2020
WIN Flexible Nail System
Biomet, Inc.
Orthopedic
62d
Cleared
Mar 14, 2013
CHINA NAILS AND ACCESSORIES
Smith & Nephew, Inc.
Orthopedic
83d
Cleared
Dec 05, 2011
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
Synthes (Usa)
Orthopedic
174d
Cleared
Sep 27, 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
Synthes (Usa)
Orthopedic
58d
Cleared
Mar 13, 2007
SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM
Synthes (Usa)
Orthopedic
168d
Cleared
Aug 10, 2006
KNEE FUSION NAIL
Smith & Nephew, Inc.
Orthopedic
45d
Cleared
Jun 06, 2006
TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
Smith & Nephew, Inc.
Orthopedic
54d
Cleared
Jun 30, 2005
TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS
Smith & Nephew, Inc.
Orthopedic
17d
Cleared
May 04, 2005
KNEE FUSION NAIL
Smith & Nephew, Inc.
Orthopedic
20d
Cleared
Apr 12, 2004
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
Synthes (Usa)
Orthopedic
18d
Cleared
Feb 20, 2004
TRIGEN INTERTAN
Smith & Nephew, Inc.
Orthopedic
21d
Cleared
Nov 05, 2003
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
Synthes (Usa)
Orthopedic
37d
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
Dec 04, 1998
INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
Smith & Nephew, Inc.
Orthopedic
29d
About Product Code JDS - Regulatory Context
510(k) Submission Activity
53 total 510(k) submissions under product code JDS since 1977, with 53 receiving FDA clearance (average review time: 96 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - JDS Product Code
Recent submissions under JDS have taken an average of 173 days to reach a decision - up from 91 days historically. Manufacturers should account for longer review timelines in current project planning.
JDS devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →