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
Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
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
Tgm Medical
Orthopedic
102d
Cleared
Aug 04, 2011
UNITED UTF STEM
United Orthopedic Corporation
Orthopedic
189d
Cleared
Jul 21, 2011
COREN TOTAL HIP SYSTEM
Corentec Co., Ltd.
Orthopedic
240d
Cleared
Jul 01, 2011
U2 HIP SYSTEM
United Orthopedic Corp.
Orthopedic
28d
Cleared
Jun 16, 2011
APEX K1 HIP STEM
Omni Life Science, Inc.
Orthopedic
73d
Cleared
Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
Zimmer, Inc.
Orthopedic
121d
Cleared
Apr 11, 2011
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
Howmedica Osteonics Corp.
Orthopedic
357d
Cleared
Apr 01, 2011
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
Consensus Orthopedics, Inc.
Orthopedic
36d
Cleared
Mar 24, 2011
ARCOMXL ACTIVE ARTICULATION
Biomet Manufacturing Corp
Orthopedic
24d
Cleared
Mar 21, 2011
MPACT ACETABULAR SYSTEM
Medacta International
Orthopedic
90d
Cleared
Mar 16, 2011
ESCALADE ACETABULAR CUP SYSTEM
Ortho Development
Orthopedic
118d
Cleared
Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
Smith & Nephew, Inc.
Orthopedic
89d
Cleared
Jan 14, 2011
E1 AVANTAGE HEAD
Biomet Manufacturing Corp
Orthopedic
247d
Cleared
Dec 03, 2010
KLASSIC HD HIP SYSTEM
Total Joint Orthopedics, Inc.
Orthopedic
289d
Cleared
Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
Zimmer, Inc.
Orthopedic
214d
Cleared
Dec 02, 2010
CONSENSUS TAPERSET HIP SYSTEM
Consensus Orthopedics, Inc.
Orthopedic
100d
Cleared
Nov 19, 2010
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
Stryker Corporation
Orthopedic
28d
Cleared
Nov 05, 2010
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
Exactech, Inc.
Orthopedic
30d
Cleared
Oct 29, 2010
DEPUY PINNACLE ALTRX ACETABULAR LINERS
DePuy Orthopaedics, Inc.
Orthopedic
65d
Cleared
Oct 06, 2010
CONSENSUS CS2 PLUS ACETABULAR INSERT
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
Exactech, Inc.
Orthopedic
90d
Cleared
Sep 14, 2010
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
Omni Life Science, Inc.
Orthopedic
63d
Cleared
May 27, 2010
NOVATION CROWN CUP GXL LINERS
Exactech, Inc.
Orthopedic
118d