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 Smith & Nephew, Inc..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
193–216 of 564
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Sep 06, 2011
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON
K111472
Tgm Medical
Orthopedic · 102d
Cleared Aug 04, 2011
UNITED UTF STEM
K110245
United Orthopedic Corporation
Orthopedic · 189d
Cleared Jul 21, 2011
COREN TOTAL HIP SYSTEM
K103431
Corentec Co., Ltd.
Orthopedic · 240d
Cleared Jul 01, 2011
U2 HIP SYSTEM
K111546
United Orthopedic Corp.
Orthopedic · 28d
Cleared Jun 16, 2011
APEX K1 HIP STEM
K110947
Omni Life Science, Inc.
Orthopedic · 73d
Cleared Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662
Zimmer, Inc.
Orthopedic · 121d
Cleared Apr 11, 2011
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072
Howmedica Osteonics Corp.
Orthopedic · 357d
Cleared Apr 01, 2011
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
K110542
Consensus Orthopedics, Inc.
Orthopedic · 36d
Cleared Mar 24, 2011
ARCOMXL ACTIVE ARTICULATION
K110555
Biomet Manufacturing Corp
Orthopedic · 24d
Cleared Mar 21, 2011
MPACT ACETABULAR SYSTEM
K103721
Medacta International
Orthopedic · 90d
Cleared Mar 16, 2011
ESCALADE ACETABULAR CUP SYSTEM
K103384
Ortho Development
Orthopedic · 118d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 14, 2011
E1 AVANTAGE HEAD
K101336
Biomet Manufacturing Corp
Orthopedic · 247d
Cleared Dec 03, 2010
KLASSIC HD HIP SYSTEM
K100445
Total Joint Orthopedics, Inc.
Orthopedic · 289d
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
K101229
Zimmer, Inc.
Orthopedic · 214d
Cleared Dec 02, 2010
CONSENSUS TAPERSET HIP SYSTEM
K102399
Consensus Orthopedics, Inc.
Orthopedic · 100d
Cleared Nov 19, 2010
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
K103124
Stryker Corporation
Orthopedic · 28d
Cleared Nov 05, 2010
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
K102975
Exactech, Inc.
Orthopedic · 30d
Cleared Oct 29, 2010
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K102423
DePuy Orthopaedics, Inc.
Orthopedic · 65d
Cleared Oct 06, 2010
CONSENSUS CS2 PLUS ACETABULAR INSERT
K100933
Consensus Orthopedics, Inc.
Orthopedic · 184d
Cleared Sep 21, 2010
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13
K101761
Exactech, Inc.
Orthopedic · 90d
Cleared Sep 14, 2010
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
K101976
Omni Life Science, Inc.
Orthopedic · 63d
Cleared May 27, 2010
NOVATION CROWN CUP GXL LINERS
K100269
Exactech, Inc.
Orthopedic · 118d