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
May 22, 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
Sulzer Orthopedics, Inc.
Orthopedic
85d
Cleared
May 22, 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
Sulzer Orthopedics, Inc.
Orthopedic
85d
Cleared
Apr 30, 1997
PEGGED ACETABULAR COMPONENT
Biomet, Inc.
Orthopedic
79d
Cleared
Mar 13, 1997
IMPLEX REPLACEMENT ACETABULAR CUP INSERT
Implex Corp.
Orthopedic
98d
Cleared
Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
Howmedica Corp.
Orthopedic
79d
Cleared
Mar 07, 1997
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
Osteoimplant Technology, Inc.
Orthopedic
88d
Cleared
Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
78d
Cleared
Feb 12, 1997
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
Endotec, Inc.
Orthopedic
187d
Cleared
Feb 12, 1997
B-P HEMISPHERICAL ACETABULAR COMPONENT
Endotec, Inc.
Orthopedic
187d
Cleared
Jan 27, 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
Smith & Nephew Richards, Inc.
Orthopedic
146d
Cleared
Jan 27, 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
Osteonics Corp.
Orthopedic
117d
Cleared
Jan 27, 1997
METAL BACKED ACETABULAR COMPONENT
Encore Orthopedics, Inc.
Orthopedic
112d
Cleared
Jan 14, 1997
MAYO HIP PROSTHESIS
Mayo Clinic
Orthopedic
923d
Cleared
Jan 14, 1997
METAL ACETABULAR COMPONENT
Encore Orthopedics, Inc.
Orthopedic
83d
Cleared
Nov 12, 1996
APEX HOLE ELIMINATOR PS
Depuy, Inc.
Orthopedic
82d
Cleared
Oct 15, 1996
NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
Intermedics Orthopedics
Orthopedic
56d
Cleared
Oct 03, 1996
HORIZON HIP SYSTEM
Biologically Oriented Prostheses
Orthopedic
79d
Cleared
Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
Depuy, Inc.
Orthopedic
64d
Cleared
Sep 17, 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
Depuy, Inc.
Orthopedic
175d
Cleared
Sep 17, 1996
PRESS-FIT POROUS SHELL
Encore Orthopedics, Inc.
Orthopedic
148d
Cleared
Sep 10, 1996
QUATROLOC FEMORAL COMPONENT & HEAD
Whiteside Biomechanics, Inc.
Orthopedic
137d
Cleared
Aug 13, 1996
S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
Johnson & Johnson Professionals, Inc.
Orthopedic
85d
Cleared
Aug 09, 1996
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
Encore Orthopedics, Inc.
Orthopedic
247d
Cleared
Jun 21, 1996
FENNING FEMORAL COMPONENT
Biomet, Inc.
Orthopedic
151d