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 Smith & Nephew, Inc..
562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
Cleared
Dec 22, 1999
MODULAR REACH HIP
Biomet, Inc.
Orthopedic
23d
Cleared
Dec 20, 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
Howmedica Osteonics Corp.
Orthopedic
280d
Cleared
Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
Exactech, Inc.
Orthopedic
65d
Cleared
Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
Howmedica Osteonics Corp.
Orthopedic
45d
Cleared
Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
Zimmer, Inc.
Orthopedic
79d
Cleared
Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
Smith & Nephew, Inc.
Orthopedic
207d
Cleared
Aug 12, 1999
ENCORE FULLY COATED HIP
Encore Orthopedics, Inc.
Orthopedic
51d
Cleared
Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
Zimmer, Inc.
Orthopedic
180d
Cleared
Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
Smith & Nephew, Inc.
Orthopedic
75d
Cleared
Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
Biomet, Inc.
Orthopedic
43d
Cleared
Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
Implex Corp.
Orthopedic
244d
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
Feb 24, 1999
ECHELON HIP STEM
Smith & Nephew, Inc.
Orthopedic
117d
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