JDG · Class II · 21 CFR 888.3360

FDA Product Code JDG: Prosthesis, Hip, Femoral Component, Cemented, Metal

Leading manufacturers include Howmedica Corp., Biomet, Inc. and Orthopedic Equipment Co., Inc..

59
Total
59
Cleared
101d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Prosthesis, Hip, Femoral Component, Cemented, Metal Devices (Product Code JDG)

59 devices
1–24 of 59
Cleared Feb 07, 2022
Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
K212431
Biomet, Inc.
Orthopedic · 187d
Cleared Sep 25, 2020
Distal Centralizers
K193546
Biomet, Inc.
Orthopedic · 280d
Cleared Mar 19, 2018
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K173499
Stryker Orthopaedics
Orthopedic · 126d
Cleared Sep 27, 2000
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
K001984
Stelkast Company
Orthopedic · 90d
Cleared Nov 10, 1999
THE TAPER-FIT TOTAL HIP SYSTEM
K992234
Corin USA
Orthopedic · 131d
Cleared Aug 08, 1996
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002
Exactech, Inc.
Orthopedic · 78d
Cleared Aug 21, 1995
HIP FRACTURE STEM FENESTRATION PLUG
K953067
Howmedica Corp.
Orthopedic · 52d
Cleared May 30, 1995
ORTHOMET TITANIUM HYBRID FEMORAL STEM
K945783
Orthomet, Inc.
Orthopedic · 186d
Cleared May 22, 1995
PROFORM CEMENTED FEMORAL COMPONENT
K951083
Stelkast Company
Orthopedic · 74d
Cleared Sep 20, 1994
INTEGRAL CO-CR FEMORAL COMPONENT
K942479
Biomet, Inc.
Orthopedic · 118d
Cleared Sep 19, 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027
Biomet, Inc.
Orthopedic · 146d
Cleared Sep 19, 1994
RX90 FEMORAL COMPONENT
K942028
Biomet, Inc.
Orthopedic · 146d
Cleared May 05, 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194
Biomet, Inc.
Orthopedic · 422d
Cleared Feb 23, 1994
BRIDGE(TM) HIP SYSTEM
K933871
Wrightmedicaltechnologyinc
Orthopedic · 198d
Cleared Apr 29, 1993
STABILITY HIP STEM WITH POROCOAT
K915787
Depuy, Inc.
Orthopedic · 492d
Cleared Jul 12, 1991
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
K911595
Dow Corning Wright
Orthopedic · 94d
Cleared Jan 26, 1988
OPTI-FIX COLLARED FEMORAL COMPONENTS
K874868
Richards Medical Co., Inc.
Orthopedic · 60d
Cleared Jan 07, 1988
PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K874575
Dow Corning Wright
Orthopedic · 62d
Cleared Dec 31, 1987
AML CALCAR FEMORAL PROSTHESIS
K874100
Depuy, Inc.
Orthopedic · 84d
Cleared Dec 30, 1987
CTI STRAIGHT STEM
K873627
Orthopedic Systems, Inc.
Orthopedic · 113d
Cleared Dec 18, 1987
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO
K874740
Dow Corning Wright
Orthopedic · 30d
Cleared Dec 10, 1987
THOMPSON HIP PROSTHESIS
K874617
Orthopedic Systems, Inc.
Orthopedic · 31d
Cleared Sep 23, 1987
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458
Howmedica Corp.
Orthopedic · 26d
Cleared Sep 16, 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089
Howmedica Corp.
Orthopedic · 42d

About Product Code JDG - Regulatory Context

510(k) Submission Activity

59 total 510(k) submissions under product code JDG since 1976, with 59 receiving FDA clearance (average review time: 101 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.