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..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
289–312 of 564
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 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
Cleared May 01, 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733
Zimmer, Inc.
Orthopedic · 52d
Cleared Apr 24, 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Mar 20, 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501
Biomet, Inc.
Orthopedic · 29d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520
United Orthopedic Corp.
Orthopedic · 210d
Cleared Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 05, 2003
HA PMI FEMORAL HIP STEM
K030048
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079
Zimmer, Inc.
Orthopedic · 27d
Cleared Nov 08, 2002
HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
K023409
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 06, 2002
ARCPM 1050 RESIN-HIPS
K023357
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 02, 2002
SMITH & NEPHEW HIP SYSTEM
K022902
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891
Zimmer, Inc.
Orthopedic · 90d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556
Smith & Nephew, Inc.
Orthopedic · 26d