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