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 Howmedica Osteonics Corp..
531
Total
531
Cleared
144d
Avg days
1985
Since
531 devices
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