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.
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented Devices (Product Code LZO)
About Product Code LZO - Regulatory Context
510(k) Submission Activity
529 total 510(k) submissions under product code LZO since 1985, with 529 receiving FDA clearance (average review time: 144 days).
Submission volume has remained relatively stable over the observed period, with 24 submissions in the last 24 months.
FDA Review Time
FDA review times for LZO submissions have been consistent, averaging 136 days recently vs 145 days historically.
LZO devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →