FDA Product Code LZO: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Hip replacement surgery restores mobility and eliminates pain in patients with advanced joint disease. FDA product code LZO covers semi-constrained hip prostheses with metal, ceramic, or polymer bearing surfaces.
These implants replace the femoral head and acetabular socket with engineered bearing couples designed to minimize wear and maximize longevity. Material combinations include metal-on-polyethylene, ceramic-on-ceramic, and ceramic-on-polyethylene.
LZO devices are Class II medical devices, regulated under 21 CFR 888.3353 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Howmedica Osteonics Corp. and Medacta International S.A..
529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
Cleared
Feb 16, 1994
BIMETRIC TOTAL HIP SYSTEM
Biomet, Inc.
Orthopedic
705d
Cleared
Feb 16, 1994
INTEGRAL TOTAL HIP SYSTEM
Biomet, Inc.
Orthopedic
705d
Cleared
Jun 22, 1993
WALKER HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
580d
Cleared
Nov 04, 1992
ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER
Biomet, Inc.
Orthopedic
323d
Cleared
May 15, 1992
HOWEDICA ZIRCONIA FEMORAL HEAD
Howmedica Corp.
Orthopedic
95d
Cleared
Jan 16, 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
Biomet, Inc.
Orthopedic
175d
Cleared
Jan 13, 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
Zimmer, Inc.
Orthopedic
87d
Cleared
Apr 15, 1991
ZIRCONIA CERAMIC MODULAR HEADS
Biomet, Inc.
Orthopedic
117d
Cleared
Mar 07, 1991
ZIMMER CERAMIC FEMORAL HEADS
Zimmer, Inc.
Orthopedic
73d
Cleared
Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
Depuy, Inc.
Orthopedic
100d
Cleared
Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
Depuy, Inc.
Orthopedic
100d
Cleared
Mar 15, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
Depuy, Inc.
Orthopedic
65d
Cleared
Jun 17, 1986
THREADED TITANIUM METAL BACKED ACETABULAR CUP
Depuy, Inc.
Orthopedic
63d
Cleared
Mar 05, 1985
THREADED TITANIUM METAL BACKED ACETABULAR CUP
Depuy, Inc.
Orthopedic
78d