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..
564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
Cleared
Jan 28, 1998
FOUNDATION POROUS ACETABULAR SYSTEM
Encore Orthopedics, Inc.
Orthopedic
161d
Cleared
Jan 28, 1998
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
Encore Orthopedics, Inc.
Orthopedic
90d
Cleared
Jan 28, 1998
FOUNDATION POROUS COATED FLARED RIM SHELL
Encore Orthopedics, Inc.
Orthopedic
90d
Cleared
Jan 12, 1998
ENCORE LINEAR POROUS COATED HIP
Encore Orthopedics, Inc.
Orthopedic
59d
Cleared
Dec 24, 1997
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
86d
Cleared
Dec 19, 1997
NATURAL-HIP POROUS STEM WITH OFFSET
Sulzer Orthopedics, Inc.
Orthopedic
84d
Cleared
Dec 19, 1997
REVELATION POROUS HIP STEM
Encore Orthopedics, Inc.
Orthopedic
84d
Cleared
Dec 04, 1997
REACH FEMORAL HIP COMPONENT
Biomet, Inc.
Orthopedic
202d
Cleared
Dec 02, 1997
FOUNDATION POROUS HIP STEM
Encore Orthopedics, Inc.
Orthopedic
90d
Cleared
Nov 21, 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
Howmedica Corp.
Orthopedic
88d
Cleared
Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
Depuy, Inc.
Orthopedic
124d
Cleared
Nov 03, 1997
APR POROUS HA HIP SYSTEM
Sulzer Orthopedics, Inc.
Orthopedic
75d
Cleared
Oct 24, 1997
SMC ACETABULAR COMPONENT
Signal Medical Corp.
Orthopedic
218d
Cleared
Oct 16, 1997
INFINTY DISTAL FEMORAL COMPONENT
Wrightmedicaltechnologyinc
Orthopedic
28d
Cleared
Sep 19, 1997
INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI)
Sulzer Orthopedics, Inc.
Orthopedic
85d
Cleared
Aug 14, 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
Depuy, Inc.
Orthopedic
204d
Cleared
Aug 07, 1997
QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
Whiteside Biomechanics, Inc.
Orthopedic
287d
Cleared
Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
Howmedica Corp.
Orthopedic
71d
Cleared
Jul 23, 1997
MICRO-SEAL ACETABULAR SYSTEM
Whiteside Biomechanics, Inc.
Orthopedic
75d
Cleared
Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
Wrightmedicaltechnologyinc
Orthopedic
82d
Cleared
Jul 03, 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
Intermedics Orthopedics
Orthopedic
160d
Cleared
Jun 19, 1997
IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
Implex Corp.
Orthopedic
223d
Cleared
Jun 19, 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
Depuy, Inc.
Orthopedic
211d
Cleared
Jun 18, 1997
LSF TRIAD TOTAL HIP SYSTEM
Osteoimplant Technology, Inc.
Orthopedic
90d