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..

562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
121–144 of 562
Cleared Aug 30, 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207
United Orthopedic Corporation
Orthopedic · 45d
Cleared Jun 21, 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099
Encore Medical, L.P.
Orthopedic · 157d
Cleared Jun 06, 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149
United Orthopedic Corporation
Orthopedic · 135d
Cleared May 01, 2013
UTF STEM, REDUCED
K123550
United Orthopedic Corporation
Orthopedic · 163d
Cleared Apr 19, 2013
ARCOS TROCHANTER BUTTON
K130063
Biomet, Inc.
Orthopedic · 99d
Cleared Dec 28, 2012
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
K121297
Signature Orthopaedics Pty, Ltd.
Orthopedic · 242d
Cleared Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
K112898
Lima Corporate S.P.A.
Orthopedic · 445d
Cleared Nov 02, 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636
Encore Medical, L.P.
Orthopedic · 65d
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 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 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 Jun 19, 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
K121024
Encore Medical, L.P.
Orthopedic · 76d
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 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Aug 04, 2011
UNITED UTF STEM
K110245
United Orthopedic Corporation
Orthopedic · 189d
Cleared Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662
Zimmer, Inc.
Orthopedic · 121d