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
25–48 of 81
Cleared Oct 21, 1998
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936
Osteonics Corp.
Orthopedic · 61d
Cleared Nov 13, 1997
PLUS-FIT ACETABULAR CUP
K973077
Plus Orthopedics
Orthopedic · 87d
Cleared May 05, 1997
PRESS-FIT HIP STEM
K964178
Encore Orthopedics, Inc.
Orthopedic · 199d
Cleared Oct 24, 1996
PERFECTA REVISION HIP SYSTEM
K955553
Wrightmedicaltechnologyinc
Orthopedic · 324d
Cleared Oct 08, 1996
DELTA HIP PROSTHESIS
K961378
Zimmer, Inc.
Orthopedic · 181d
Cleared Oct 01, 1996
PRESS-FIT FLARED SHELL
K960633
Encore Orthopedics, Inc.
Orthopedic · 230d
Cleared Oct 01, 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155
Intermedics Orthopedics
Orthopedic · 57d
Cleared Aug 08, 1996
SRRS PRESSED FIT FEMORAL REVISION COMPONENT
K960908
Stelkast Company
Orthopedic · 156d
Cleared Feb 15, 1996
INTERMOORE FRACTURE HIP STEM
K954854
Intermedics Orthopedics
Orthopedic · 115d
Cleared Feb 14, 1996
LFIC OR FETTO HIP
K952776
Zimmer, Inc.
Orthopedic · 243d
Cleared Jan 17, 1996
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
K953268
Stelkast Company
Orthopedic · 188d
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 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 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 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