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 Apr 14, 1993
INTRINSIC STEM
K923911
Turnkey Intergration USA, Inc.
Orthopedic · 253d
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 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
Cleared Jun 06, 1989
KDG ACETABULAR COMPONENT
K891262
Osteonics Corp.
Orthopedic · 90d
Cleared May 26, 1989
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K883794
Protek, Inc.
Orthopedic · 261d
Cleared Feb 08, 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661
Depuy, Inc.
Orthopedic · 166d
Cleared Oct 13, 1988
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921
Osteonics Corp.
Orthopedic · 27d
Cleared Oct 06, 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983
Howmedica Corp.
Orthopedic · 147d
Cleared Jun 29, 1988
CORIN MODULAR MOORE STEM
K881288
Orthopedic Systems, Inc.
Orthopedic · 93d
Cleared Apr 22, 1988
S-ROM SUPERCUP ACETABULAR CUP
K870088
Joint Medical Products Corp.
Orthopedic · 469d
Cleared Nov 02, 1987
TI-FIT TOTAL HIP SYSTEM
K873797
Richards Medical Co., Inc.
Orthopedic · 45d
Cleared Jan 27, 1984
MICRO-STRUCTURED HS2P HIP STEMS
K833970
Osteonics Corp.
Orthopedic · 72d