LPH · Class II · 21 CFR 888.3358

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
433–456 of 564
Cleared May 22, 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
K970705
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
K970706
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501
Biomet, Inc.
Orthopedic · 79d
Cleared Mar 13, 1997
IMPLEX REPLACEMENT ACETABULAR CUP INSERT
K964882
Implex Corp.
Orthopedic · 98d
Cleared Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 07, 1997
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
K964924
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 12, 1997
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
K963100
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
B-P HEMISPHERICAL ACETABULAR COMPONENT
K963101
Endotec, Inc.
Orthopedic · 187d
Cleared Jan 27, 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
K963509
Smith & Nephew Richards, Inc.
Orthopedic · 146d
Cleared Jan 27, 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946
Osteonics Corp.
Orthopedic · 117d
Cleared Jan 27, 1997
METAL BACKED ACETABULAR COMPONENT
K963998
Encore Orthopedics, Inc.
Orthopedic · 112d
Cleared Jan 14, 1997
MAYO HIP PROSTHESIS
K943230
Mayo Clinic
Orthopedic · 923d
Cleared Jan 14, 1997
METAL ACETABULAR COMPONENT
K964227
Encore Orthopedics, Inc.
Orthopedic · 83d
Cleared Nov 12, 1996
APEX HOLE ELIMINATOR PS
K963309
Depuy, Inc.
Orthopedic · 82d
Cleared Oct 15, 1996
NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED
K963266
Intermedics Orthopedics
Orthopedic · 56d
Cleared Oct 03, 1996
HORIZON HIP SYSTEM
K962769
Biologically Oriented Prostheses
Orthopedic · 79d
Cleared Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923
Depuy, Inc.
Orthopedic · 64d
Cleared Sep 17, 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K961186
Depuy, Inc.
Orthopedic · 175d
Cleared Sep 17, 1996
PRESS-FIT POROUS SHELL
K961526
Encore Orthopedics, Inc.
Orthopedic · 148d
Cleared Sep 10, 1996
QUATROLOC FEMORAL COMPONENT & HEAD
K961625
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)
K961939
Johnson & Johnson Professionals, Inc.
Orthopedic · 85d
Cleared Aug 09, 1996
FOUNDATION FORGED, TEXTURED & POROUS STEMS W/BIOLOX CERAMIC HEADS
K955563
Encore Orthopedics, Inc.
Orthopedic · 247d
Cleared Jun 21, 1996
FENNING FEMORAL COMPONENT
K960303
Biomet, Inc.
Orthopedic · 151d