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..
564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
Cleared
Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
Encore Orthopedics, Inc.
Orthopedic
67d
Cleared
Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
Wrightmedicaltechnologyinc
Orthopedic
60d
Cleared
Apr 30, 1999
B2C, ESPACE REVISION CUP SYSTEM
Turnkey Intergration USA, Inc.
Orthopedic
70d
Cleared
Mar 15, 1999
TIGRAN HIP PROSTHESIS
Ponmed , Ltd.
Orthopedic
88d
Cleared
Feb 24, 1999
ECHELON HIP STEM
Smith & Nephew, Inc.
Orthopedic
117d
Cleared
Feb 24, 1999
J-SERIES OMEGA TOTAL HIP SYSTEM
Osteoimplant Technology, Inc.
Orthopedic
51d
Cleared
Feb 18, 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
79d
Cleared
Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
65d
Cleared
Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
Sulzer Orthopedics, Inc.
Orthopedic
119d
Cleared
Jan 28, 1999
DEPUY PROFILE FEMORAL HIP WITH POROCOAT
DePuy Orthopaedics, Inc.
Orthopedic
44d
Cleared
Dec 16, 1998
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
Osteonics Corp.
Orthopedic
71d
Cleared
Dec 02, 1998
DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
DePuy Orthopaedics, Inc.
Orthopedic
58d
Cleared
Nov 23, 1998
CUSTOM FLANGED ACETABULAR COMPONENT
Biomet, Inc.
Orthopedic
84d
Cleared
Nov 12, 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
Zimmer, Inc.
Orthopedic
261d
Cleared
Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
Johnson & Johnson Professionals, Inc.
Orthopedic
60d
Cleared
Aug 31, 1998
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
Howmedica, Inc.
Orthopedic
66d
Cleared
Aug 24, 1998
REACH HIP COMPONENT
Biomet, Inc.
Orthopedic
48d
Cleared
May 22, 1998
APR -T REVISION HIP STEM
Sulzer Orthopedics, Inc.
Orthopedic
50d
Cleared
May 20, 1998
OMEGA HA COATED TOTAL HIP SYSTEM
Osteoimplant Technology, Inc.
Orthopedic
64d
Cleared
Apr 03, 1998
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
Metagen, LLC
Orthopedic
88d
Cleared
Mar 18, 1998
DEPUY TRI-LOCK HIP STEM
Depuy, Inc.
Orthopedic
89d
Cleared
Feb 27, 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
Osteoimplant Technology, Inc.
Orthopedic
88d
Cleared
Feb 11, 1998
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
Howmedica Corp.
Orthopedic
336d
Cleared
Feb 06, 1998
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
Johnson & Johnson Professionals, Inc.
Orthopedic
80d