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
Nov 05, 2012
CS2 HIP SYSTEM
Consensus Orthopedics, Inc.
Orthopedic
80d
Cleared
Nov 02, 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
Encore Medical, L.P.
Orthopedic
65d
Cleared
Oct 24, 2012
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
Tgm Medical, Inc.
Orthopedic
142d
Cleared
Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
Smith & Nephew, Inc.
Orthopedic
26d
Cleared
Oct 22, 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
Zimmer, Inc.
Orthopedic
24d
Cleared
Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
Exactech, Inc.
Orthopedic
29d
Cleared
Oct 10, 2012
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
United Orthopedic Corporation
Orthopedic
55d
Cleared
Oct 05, 2012
BENCOX II STEM, BENCOX METAL HEAD
Corentec Co., Ltd.
Orthopedic
81d
Cleared
Oct 01, 2012
NOVATION LPI PRIME FEMORAL STEM
Exactech, Inc.
Orthopedic
116d
Cleared
Sep 14, 2012
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
Zimmer, Inc.
Orthopedic
311d
Cleared
Sep 10, 2012
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
Corentec Co., Ltd.
Orthopedic
167d
Cleared
Sep 10, 2012
TAPERSET HIP SMALL STEMS
Consensus Orthopedics, Inc.
Orthopedic
70d
Cleared
Sep 04, 2012
IOI TOTAL HIP
Iconacy Orthopedic Implants, LLC
Orthopedic
152d
Cleared
Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
Smith & Nephew, Inc.
Orthopedic
27d
Cleared
Aug 17, 2012
TAPERLOC COMPLETE SIZE 4MM AND XR 123
Biomet Manufacturing Corp
Orthopedic
226d
Cleared
Jul 30, 2012
HIP SYSTEMS
Howmedica Osteonics Corp.
Orthopedic
90d
Cleared
Jul 18, 2012
U2 ACETABULAR CUP, PLASMA SPRAY
United Orthopedic Corp.
Orthopedic
30d
Cleared
Jun 19, 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
Encore Medical, L.P.
Orthopedic
76d
Cleared
May 22, 2012
TAPER SET HIP SYSTEM RDP STEM
Consensus Orthopedics, Inc.
Orthopedic
26d
Cleared
May 10, 2012
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
Lima Corporate S.P.A.
Orthopedic
288d
Cleared
Feb 24, 2012
LINEAR HIP STEM, SIZE 5
Encore Medical, L.P.
Orthopedic
28d
Cleared
Jan 05, 2012
APEX ARC HIP STEM
Omni Life Science, Inc.
Orthopedic
64d
Cleared
Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
Exactech, Inc.
Orthopedic
29d
Cleared
Dec 02, 2011
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
Omnlife Science
Orthopedic
67d