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
169–192 of 564
Cleared Nov 05, 2012
CS2 HIP SYSTEM
K122512
Consensus Orthopedics, Inc.
Orthopedic · 80d
Cleared Nov 02, 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636
Encore Medical, L.P.
Orthopedic · 65d
Cleared Oct 24, 2012
ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
K121636
Tgm Medical, Inc.
Orthopedic · 142d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 22, 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019
Zimmer, Inc.
Orthopedic · 24d
Cleared Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 10, 2012
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
K122504
United Orthopedic Corporation
Orthopedic · 55d
Cleared Oct 05, 2012
BENCOX II STEM, BENCOX METAL HEAD
K122099
Corentec Co., Ltd.
Orthopedic · 81d
Cleared Oct 01, 2012
NOVATION LPI PRIME FEMORAL STEM
K121684
Exactech, Inc.
Orthopedic · 116d
Cleared Sep 14, 2012
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
K113296
Zimmer, Inc.
Orthopedic · 311d
Cleared Sep 10, 2012
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
K120924
Corentec Co., Ltd.
Orthopedic · 167d
Cleared Sep 10, 2012
TAPERSET HIP SMALL STEMS
K121935
Consensus Orthopedics, Inc.
Orthopedic · 70d
Cleared Sep 04, 2012
IOI TOTAL HIP
K121034
Iconacy Orthopedic Implants, LLC
Orthopedic · 152d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 17, 2012
TAPERLOC COMPLETE SIZE 4MM AND XR 123
K120030
Biomet Manufacturing Corp
Orthopedic · 226d
Cleared Jul 30, 2012
HIP SYSTEMS
K121308
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jul 18, 2012
U2 ACETABULAR CUP, PLASMA SPRAY
K121777
United Orthopedic Corp.
Orthopedic · 30d
Cleared Jun 19, 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
K121024
Encore Medical, L.P.
Orthopedic · 76d
Cleared May 22, 2012
TAPER SET HIP SYSTEM RDP STEM
K121263
Consensus Orthopedics, Inc.
Orthopedic · 26d
Cleared May 10, 2012
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
K112158
Lima Corporate S.P.A.
Orthopedic · 288d
Cleared Feb 24, 2012
LINEAR HIP STEM, SIZE 5
K120241
Encore Medical, L.P.
Orthopedic · 28d
Cleared Jan 05, 2012
APEX ARC HIP STEM
K113242
Omni Life Science, Inc.
Orthopedic · 64d
Cleared Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609
Exactech, Inc.
Orthopedic · 29d
Cleared Dec 02, 2011
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
K112779
Omnlife Science
Orthopedic · 67d