JDO · Class II · 21 CFR 888.3030

FDA Product Code JDO: Device, Fixation, Proximal Femoral, Implant

Leading manufacturers include Synthes (Usa), Biomet, Inc. and Smith & Nephew, Inc..

23
Total
23
Cleared
115d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Device, Fixation, Proximal Femoral, Implant Devices (Product Code JDO)

23 devices
1–23 of 23
Cleared Apr 18, 2023
OsteoCentric Integrated Hip Fastener System
K230764
OsteoCentric Technologies
Orthopedic · 29d
Cleared Sep 29, 2022
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws
K213126
Smith & Nephew, Inc.
Orthopedic · 367d
Cleared Apr 30, 2021
OsteoCentric Integrated Hip Fastener System
K210247
Osteocentric Technologies D.B.A. Osteocentric Trauma
Orthopedic · 91d
Cleared Feb 28, 2020
CONQUEST FN
K193029
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Feb 07, 2018
THP Hip Fracture Plating System
K173826
Biomet, Inc.
Orthopedic · 51d
Cleared Apr 04, 2014
TSP HIP FRACTURE PLATING SYSTEM
K140018
Biomet, Inc.
Orthopedic · 91d
Cleared Apr 10, 2008
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jul 17, 1998
SYNTHES (USA) DHS HELIX SYSTEM
K981757
Synthes (Usa)
Orthopedic · 59d
Cleared Jan 09, 1997
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259
Synthes (Usa)
Orthopedic · 76d
Cleared Mar 08, 1996
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
K953607
Synthes (Usa)
Orthopedic · 219d
Cleared Jul 17, 1995
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 22, 1993
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
K923613
Synthes (Usa)
Orthopedic · 336d
Cleared Mar 05, 1981
PROXIMAL FERMORAL HIP REPLACEMENT
K810258
Biomet, Inc.
Orthopedic · 34d
Cleared Aug 21, 1978
BIOMET CONCENTRIC HEX SCREW
K781389
Biomet, Inc.
Orthopedic · 11d
Cleared Mar 15, 1978
NAIL, MASSIE II
K780187
Howmedica Corp.
Orthopedic · 37d

About Product Code JDO - Regulatory Context

510(k) Submission Activity

23 total 510(k) submissions under product code JDO since 1978, with 23 receiving FDA clearance (average review time: 115 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.