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..
565
Total
565
Cleared
152d
Avg days
1984
Since
565 devices
Cleared
Apr 28, 2006
CONSENSUS ACETABULAR SHELL SYSTEM
Hayes Medical, Inc.
Orthopedic
49d
Cleared
Feb 17, 2006
XR-SERIES BI-METRIC FEMORAL COMPONENTS
Biomet Manufacturing, Inc.
Orthopedic
199d
Cleared
Feb 16, 2006
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
Ortho Development Corp.
Orthopedic
83d
Cleared
Feb 15, 2006
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
174d
Cleared
Jan 31, 2006
DEPUY MODULAR M HEADS
DePuy Orthopaedics, Inc.
Orthopedic
26d
Cleared
Jan 20, 2006
ESKA-LIBUR HIP STEM
Eska Implants GmbH & Co.
Orthopedic
30d
Cleared
Dec 05, 2005
LINEAGE A-CLASS POLY LINER
Wrightmedicaltechnologyinc
Orthopedic
131d
Cleared
Nov 23, 2005
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
Biomet, Inc.
Orthopedic
97d
Cleared
Sep 27, 2005
E-POLY (VITAMIN E) ACETABULAR LINERS
Biomet, Inc.
Orthopedic
230d
Cleared
Sep 06, 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
Exactech, Inc.
Orthopedic
85d
Cleared
Jun 30, 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
24d
Cleared
May 11, 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
Zimmer Trabecular
Orthopedic
27d
Cleared
Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
Biomet, Inc.
Orthopedic
181d
Cleared
Apr 11, 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
Ortho Development Corp.
Orthopedic
202d
Cleared
Mar 08, 2005
ARCOMXL POLYETHYLENE LINERS
Biomet, Inc.
Orthopedic
221d
Cleared
Feb 10, 2005
TRIDENT ACETABULAR SYSTEM
Howmedica Osteonics Corp.
Orthopedic
442d
Cleared
Feb 10, 2005
APEX MODULAR HA HIP STEM
Apex Surgical, LLC
Orthopedic
90d
Cleared
Jan 21, 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
Biomet, Inc.
Orthopedic
108d
Cleared
Jan 14, 2005
TAPERLOC 12/14 TAPER FEMORAL COMPONENTS
Biomet, Inc.
Orthopedic
23d
Cleared
Dec 21, 2004
MEDALLION MODULAR HIP SYSTEM
Biomet Manufacturing, Inc.
Orthopedic
166d
Cleared
Dec 21, 2004
APEX K2 HIP SYSTEM
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
Zimmer Trabecular
Orthopedic
64d
Cleared
Dec 06, 2004
NEXFLEX TOTAL HIP SYSTEM
Alphatec/Nexmed
Orthopedic
108d
Cleared
Nov 22, 2004
PERFECTA FEMORAL STEM
Wrightmedicaltechnologyinc
Orthopedic
567d