FDA Product Code LPH: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Under FDA product code LPH, semi-constrained hip prostheses with metal and polymer bearing surfaces are cleared for total hip arthroplasty.
These implants use a metal femoral head articulating against a polymer — typically ultra-high molecular weight polyethylene — acetabular liner. Metal-on-polymer is the most established bearing couple in hip replacement, with decades of clinical data supporting its performance.
LPH devices are Class II medical devices, regulated under 21 CFR 888.3358 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Medacta International S.A., Smith & Nephew, Inc. and Howmedica Osteonics Corp., Dba Stryker Orthopaedics.
FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented Devices (Product Code LPH)
About Product Code LPH - Regulatory Context
510(k) Submission Activity
559 total 510(k) submissions under product code LPH since 1984, with 559 receiving FDA clearance (average review time: 151 days).
Submission volume has declined in recent years - 18 submissions in the last 24 months compared to 23 in the prior period.
FDA Review Time
FDA review times for LPH submissions have been consistent, averaging 153 days recently vs 151 days historically.
LPH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →