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..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
145–168 of 561
Cleared Dec 05, 2005
LINEAGE A-CLASS POLY LINER
K052026
Wrightmedicaltechnologyinc
Orthopedic · 131d
Cleared Nov 23, 2005
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
K052255
Biomet, Inc.
Orthopedic · 97d
Cleared Sep 27, 2005
E-POLY (VITAMIN E) ACETABULAR LINERS
K050327
Biomet, Inc.
Orthopedic · 230d
Cleared Jun 30, 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491
Zimmer, Inc.
Orthopedic · 24d
Cleared Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989
Biomet, Inc.
Orthopedic · 181d
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 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 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 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 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
Cleared Mar 12, 2004
SPECTRUM MODULAR SYSTEM
K033893
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Jan 08, 2004
PINNACLE REVISION SYSTEM
K033338
DePuy Orthopaedics, Inc.
Orthopedic · 83d
Cleared Nov 05, 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034
Zimmer, Inc.
Orthopedic · 37d
Cleared Oct 22, 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 09, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581
Howmedica Osteonics Corp.
Orthopedic · 49d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055
Biomet, Inc.
Orthopedic · 217d
Cleared Aug 06, 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693
Biomet, Inc.
Orthopedic · 65d