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., Depuy Ireland UC and Implantcast GmbH.
529
Total
529
Cleared
144d
Avg days
1985
Since
529 devices
Cleared
Aug 05, 2021
EMPHASYS Femoral Stems
Depuy Ireland UC
Orthopedic
69d
Cleared
Jul 22, 2021
POLARSTEM Cemented Femoral Stem
Smith & Nephew, Inc.
Orthopedic
269d
Cleared
Jul 19, 2021
POLARSTEM Calcar Reamer Guide
Smith & Nephew, Inc.
Orthopedic
61d
Cleared
Apr 28, 2021
BI-MENTUM™ ALTRX® Dual Mobility Liner
Depuy Ireland UC
Orthopedic
147d
Cleared
Apr 16, 2021
Fusion Taper System
Signature Orthopaedics Pty, Ltd.
Orthopedic
360d
Cleared
Jan 11, 2021
M-Vizion Femoral Revision System Extension
Medacta International S.A.
Orthopedic
222d