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
Cleared
Aug 30, 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
United Orthopedic Corporation
Orthopedic
45d
Cleared
Jun 21, 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
Encore Medical, L.P.
Orthopedic
157d
Cleared
Jun 06, 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
United Orthopedic Corporation
Orthopedic
135d
Cleared
May 01, 2013
UTF STEM, REDUCED
United Orthopedic Corporation
Orthopedic
163d
Cleared
Apr 19, 2013
ARCOS TROCHANTER BUTTON
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
Signature Orthopaedics Pty, Ltd.
Orthopedic
242d
Cleared
Dec 21, 2012
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
Lima Corporate S.P.A.
Orthopedic
445d
Cleared
Nov 02, 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
Encore Medical, L.P.
Orthopedic
65d
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 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
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
Jun 19, 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
Encore Medical, L.P.
Orthopedic
76d
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 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
Exactech, Inc.
Orthopedic
29d
Cleared
Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
Smith & Nephew, Inc.
Orthopedic
269d
Cleared
Aug 04, 2011
UNITED UTF STEM
United Orthopedic Corporation
Orthopedic
189d
Cleared
Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
Zimmer, Inc.
Orthopedic
121d