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 Medacta International S.A., Smith & Nephew, Inc. and Zimmer, Inc..
531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
Cleared
Dec 14, 1989
KIM MODULAR FEMORAL HIP PROSTHESIS
Dow Corning Wright
Orthopedic
98d
Cleared
Nov 20, 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
Richards Medical Co., Inc.
Orthopedic
25d
Cleared
Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
Osteonics Corp.
Orthopedic
80d
Cleared
Sep 26, 1989
CERAMIC FEMORAL HEAD
Dow Corning Wright
Orthopedic
133d
Cleared
Sep 01, 1989
ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
Richards Medical Co., Inc.
Orthopedic
267d
Cleared
Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
Osteonics Corp.
Orthopedic
192d
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
Apr 03, 1986
TI-FIT ACETABULAR COMPONENT
Richards Medical Co., Inc.
Orthopedic
66d
Cleared
Mar 05, 1985
THREADED TITANIUM METAL BACKED ACETABULAR CUP
Depuy, Inc.
Orthopedic
78d