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
505–528 of 564
Cleared May 06, 1994
REFLECTION ACETABULAR COMPONENT
K932755
Smith & Nephew Richards, Inc.
Orthopedic · 350d
Cleared May 03, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
K932923
Implex Corp.
Orthopedic · 322d
Cleared Apr 29, 1994
RMHS MONOLITHIC FEMORAL COMPONENT
K931642
Smith & Nephew Richards, Inc.
Orthopedic · 392d
Cleared Apr 29, 1994
TRILOGY ACETABULAR SYSTEM
K934765
Zimmer, Inc.
Orthopedic · 206d
Cleared Apr 13, 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787
Depuy, Inc.
Orthopedic · 252d
Cleared Mar 21, 1994
POROCOAT POROUS COATING
K931641
Depuy, Inc.
Orthopedic · 353d
Cleared Mar 09, 1994
REPLICA(TM) TOTAL HIP SYSTEM
K926156
Osteo Technology, Inc.
Orthopedic · 457d
Cleared Mar 03, 1994
ACETABULAR SHELL
K935731
Howmedica Corp.
Orthopedic · 92d
Cleared Feb 22, 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
K921308
Zimmer, Inc.
Orthopedic · 705d
Cleared Feb 22, 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
K921557
Zimmer, Inc.
Orthopedic · 692d
Cleared Feb 22, 1994
ZIMMER ANATOMIC HIP SYSTEM
K922071
Zimmer, Inc.
Orthopedic · 659d
Cleared Feb 22, 1994
PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE)
K925172
Howmedica Corp.
Orthopedic · 496d
Cleared Feb 16, 1994
RANAWAT/BURSTEIN TOTAL HIP SYSTEM
K921277
Biomet, Inc.
Orthopedic · 701d
Cleared Feb 16, 1994
TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM
K921301
Biomet, Inc.
Orthopedic · 700d
Cleared Feb 16, 1994
PMI HIP FEMORAL
K923452
Biomet, Inc.
Orthopedic · 582d
Cleared Feb 15, 1994
METALLIC TOATAL HIP SYSTEM
K921274
Biomet, Inc.
Orthopedic · 700d
Cleared Feb 09, 1994
APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE
K920955
Intermedics Orthopedics
Orthopedic · 714d
Cleared Jan 07, 1994
PSL TOTAL HIP REPLACEMENT SYSTEM
K922500
Biopro, Inc.
Orthopedic · 590d
Cleared Oct 27, 1993
EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM
K921113
Exactech, Inc.
Orthopedic · 597d
Cleared Oct 27, 1993
EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR
K921114
Exactech, Inc.
Orthopedic · 597d
Cleared Oct 15, 1993
INFINITY POROUS-COATED TROCHANTERIC MODULE
K922159
Wrightmedicaltechnologyinc
Orthopedic · 526d
Cleared Jul 28, 1993
ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
K926107
Biomet, Inc.
Orthopedic · 237d
Cleared Jun 22, 1993
OSTEONICS MICROSUTERED FEMORAL COMPONENTES
K926201
Osteonics Corp.
General Hospital · 195d
Cleared Apr 02, 1993
HIP JOINT PROTHESIS
K921400
Smith & Nephew Richards, Inc.
Orthopedic · 374d