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..

565
Total
565
Cleared
152d
Avg days
1984
Since
565 devices
265–288 of 565
Cleared Apr 28, 2006
CONSENSUS ACETABULAR SHELL SYSTEM
K060635
Hayes Medical, Inc.
Orthopedic · 49d
Cleared Feb 17, 2006
XR-SERIES BI-METRIC FEMORAL COMPONENTS
K052089
Biomet Manufacturing, Inc.
Orthopedic · 199d
Cleared Feb 16, 2006
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS
K053293
Ortho Development Corp.
Orthopedic · 83d
Cleared Feb 15, 2006
VERSYS EPOCH FULLCOAT HIP PROSTHESIS
K052321
Zimmer, Inc.
Orthopedic · 174d
Cleared Jan 31, 2006
DEPUY MODULAR M HEADS
K060031
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared Jan 20, 2006
ESKA-LIBUR HIP STEM
K053557
Eska Implants GmbH & Co.
Orthopedic · 30d
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 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