LWJ · Class II · 21 CFR 888.3360

FDA Product Code LWJ: Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

Leading manufacturers include Plus Orthopedics, Osteonics Corp. and Stelkast Company.

81
Total
81
Cleared
144d
Avg days
1984
Since
81 devices
49–72 of 81
Cleared Jul 17, 1995
FOUNDATION TEXTURED STEM
K952297
Encore Orthopedics, Inc.
Orthopedic · 62d
Cleared Mar 21, 1995
HOWMEDICA V40 22MM FEMORAL HEAD
K950541
Howmedica Corp.
Orthopedic · 42d
Cleared Oct 13, 1994
PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
K931423
Orthomed
Orthopedic · 570d
Cleared Apr 28, 1994
COBALT CHROME GEMINI
K934909
Depuy, Inc.
Orthopedic · 196d
Cleared Mar 07, 1994
OSTEONICS 22MM, +10 NECK BEARING HEADS
K933359
Osteonics Corp.
Orthopedic · 241d
Cleared Jan 07, 1994
FUTURA TEXTURE-TRAKKED TOTAL HIP STEM
K921382
Arthronics, Inc.
Orthopedic · 655d
Cleared Apr 14, 1993
INTRINSIC STEM
K923911
Turnkey Intergration USA, Inc.
Orthopedic · 253d
Cleared Apr 01, 1992
MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
K910664
Medimix Products, Inc.
Orthopedic · 412d
Cleared Jan 27, 1992
VENUS HIP
K913708
Turnkey Intergration USA, Inc.
Orthopedic · 164d
Cleared Jan 13, 1992
TI-FIT FEMORAL COMPONENT
K914343
Smith & Nephew Richards, Inc.
Orthopedic · 108d
Cleared Mar 14, 1991
HOWMEDICA HNR SYSTEM
K903563
Howmedica Corp.
Orthopedic · 219d
Cleared Mar 12, 1991
Q SYSTEM 28 HIP STEM
K910010
Turnkey Intergration USA, Inc.
Orthopedic · 69d
Cleared Feb 26, 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254
Depuy, Inc.
Orthopedic · 95d
Cleared Feb 15, 1991
GERI TOTAL HIP SYSTEM
K905186
Smith & Nephew Richards, Inc.
Orthopedic · 88d
Cleared Sep 14, 1990
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS
K900262
3M Company
Orthopedic · 240d
Cleared Sep 14, 1990
ACSYS SHEARER ACETABULAR CUP PROSTHESIS
K900435
3M Company
Orthopedic · 227d
Cleared Sep 07, 1990
F-24 FEMORAL HIP PROSTHESIS
K901687
Med-Tek Corp.
Orthopedic · 148d
Cleared Aug 03, 1990
H.N. TOTAL HIP PROSTHESIS
K901594
Med-Tek Corp.
Orthopedic · 120d
Cleared Nov 03, 1989
KDR ACETABULAR COMPONENT
K895702
Osteonics Corp.
Orthopedic · 42d
Cleared Oct 13, 1989
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
K890331
Orthopedic Systems, Inc.
Orthopedic · 263d
Cleared Aug 28, 1989
PREMIER-TOTAL HIP
K894051
Intermedics Orthopedics
Orthopedic · 82d
Cleared Aug 09, 1989
ARC-2F ACETABULAR CUP
K893785
Protek, Inc.
Orthopedic · 79d
Cleared Jul 28, 1989
GRIPPER II ACETABULAR CUP
K893584
Joint Medical Products Corp.
Orthopedic · 80d
Cleared Jun 08, 1989
CTI II STRAIGHT STEM
K891539
Orthopedic Systems, Inc.
Orthopedic · 83d