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..

565
Total
565
Cleared
152d
Avg days
1984
Since
565 devices
289–312 of 565
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 Aug 25, 2004
BICONTACT HIP STEM AND FEMORAL HEAD
K040191
Aesculap
Orthopedic · 210d
Cleared Aug 05, 2004
NEXFLEX TOTAL HIP SYSTEM
K033580
Nexmed, Inc.
Orthopedic · 266d
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
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 Dec 03, 2003
Z-SERIES MODULAR TOTAL HIP SYSTEM
K032729
Osteoimplant Technology, Inc.
Orthopedic · 91d
Cleared Nov 13, 2003
EXACTECH 12/14 ALUMINA FEMORAL HEAD
K032964
Exactech, Inc.
Orthopedic · 51d
Cleared Nov 05, 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034
Zimmer, Inc.
Orthopedic · 37d
Cleared Oct 30, 2003
GLOBAL PRESS-FIT STEM
K032385
Global Medical Co.
Orthopedic · 87d
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
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861
Biomet, Inc.
Orthopedic · 86d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495
DePuy Orthopaedics, Inc.
Orthopedic · 29d