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 Zimmer, Inc., Biomet, Inc. and DePuy Orthopaedics, Inc..
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
561 total 510(k) submissions under product code LPH since 1984, with 561 receiving FDA clearance (average review time: 152 days).
Submission volume has remained relatively stable over the observed period, with 20 submissions in the last 24 months.
FDA 510(k) Review Time - LPH Product Code
Recent submissions under LPH have taken an average of 187 days to reach a decision - up from 151 days historically. Manufacturers should account for longer review timelines in current project planning.
LPH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →