JDG · Class II · 21 CFR 888.3360

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

Leading manufacturers include Biomet, Inc., Howmedica Corp. and Depuy, 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 Aug 21, 1995
HIP FRACTURE STEM FENESTRATION PLUG
K953067
Howmedica Corp.
Orthopedic · 52d
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 Dec 31, 1987
AML CALCAR FEMORAL PROSTHESIS
K874100
Depuy, Inc.
Orthopedic · 84d
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
Cleared Jul 30, 1985
HOWMEDICA FEMORAL COMPONENT HIP SYS 6259
K851566
Howmedica Corp.
Orthopedic · 105d
Cleared Jun 22, 1978
PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
K780773
Depuy, Inc.
Orthopedic · 49d
Cleared Apr 05, 1978
TITANIUM MULLER TOTAL HIP
K780357
Biomet, Inc.
Orthopedic · 30d
Cleared Mar 17, 1978
TOTAL HIP, NEW ENGLAND BAPTIST
K780329
Depuy, Inc.
Orthopedic · 18d
Cleared Dec 20, 1977
TOTAL HIP, CHARNELY TYPE
K772120
Depuy, Inc.
Orthopedic · 41d
Cleared Mar 24, 1977
KERBOULL-CHARNLEY CUP SPECIAL MODEL
K770471
Howmedica Corp.
Orthopedic · 14d
Cleared Mar 17, 1977
LAGRANGE LETOURNEL TOTAL HIP FEMORAL
K770473
Howmedica Corp.
Orthopedic · 7d
Cleared Feb 08, 1977
BI-CENTRIC ENDOPROSTHESES
K770184
Howmedica Corp.
Orthopedic · 12d

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.