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 Smith & Nephew, Inc..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
265–288 of 564
Cleared Sep 06, 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556
Exactech, Inc.
Orthopedic · 85d
Cleared Jun 30, 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491
Zimmer, Inc.
Orthopedic · 24d
Cleared May 11, 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
K050937
Zimmer Trabecular
Orthopedic · 27d
Cleared Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989
Biomet, Inc.
Orthopedic · 181d
Cleared Apr 11, 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
K042565
Ortho Development Corp.
Orthopedic · 202d
Cleared Mar 08, 2005
ARCOMXL POLYETHYLENE LINERS
K042051
Biomet, Inc.
Orthopedic · 221d
Cleared Feb 10, 2005
TRIDENT ACETABULAR SYSTEM
K033716
Howmedica Osteonics Corp.
Orthopedic · 442d
Cleared Feb 10, 2005
APEX MODULAR HA HIP STEM
K043123
Apex Surgical, LLC
Orthopedic · 90d
Cleared Jan 21, 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774
Biomet, Inc.
Orthopedic · 108d
Cleared Jan 14, 2005
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
K043537
Biomet, Inc.
Orthopedic · 23d
Cleared Dec 21, 2004
MEDALLION MODULAR HIP SYSTEM
K041850
Biomet Manufacturing, Inc.
Orthopedic · 166d
Cleared Dec 21, 2004
APEX K2 HIP SYSTEM
K041950
Apex Surgical, LLC
Orthopedic · 154d
Cleared Dec 21, 2004
TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3
K042871
Zimmer Trabecular
Orthopedic · 64d
Cleared Dec 06, 2004
NEXFLEX TOTAL HIP SYSTEM
K042252
Alphatec/Nexmed
Orthopedic · 108d
Cleared Nov 22, 2004
PERFECTA FEMORAL STEM
K031402
Wrightmedicaltechnologyinc
Orthopedic · 567d
Cleared Nov 09, 2004
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
K042029
Biomet, Inc.
Orthopedic · 104d
Cleared Nov 04, 2004
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337
Zimmer, Inc.
Orthopedic · 66d
Cleared Nov 04, 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
K042776
Zimmer, Inc.
Orthopedic · 29d
Cleared Sep 10, 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906
Exactech, Inc.
Orthopedic · 57d
Cleared Jul 20, 2004
ZIMMER ANATOMIC II HIP PROSTHESIS
K041109
Zimmer, Inc.
Orthopedic · 83d
Cleared May 28, 2004
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
K040544
Depuy, Inc.
Orthopedic · 87d
Cleared May 25, 2004
TRIDENT T ACETABULAR SHELLS
K040412
Stryker Orthopaedics
Orthopedic · 97d
Cleared May 12, 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared May 06, 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
K033273
DePuy Orthopaedics, Inc.
Orthopedic · 209d