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..
562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
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
Cleared
Jul 02, 1992
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
Zimmer, Inc.
Orthopedic
87d
Cleared
Jan 22, 1990
ACCESS(TM), SOFTWARE RELEASE 4.11P
Diasonics, Inc.
Radiology
59d
Cleared
Jul 30, 1986
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
Depuy, Inc.
Orthopedic
15d
Cleared
Jul 16, 1986
POROUS COATED HIP FEMORAL PROSTHESIS
Johnson & Johnson Professionals, Inc.
Orthopedic
27d
Cleared
May 06, 1986
PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
Howmedica Corp.
Orthopedic
91d
Cleared
Mar 14, 1986
OPTI-FIX TOTAL HIP SYSTEM
Richards Medical Co., Inc.
Orthopedic
22d
Cleared
Aug 22, 1985
AML PROXIMAL POROCOAT FEMORAL HIP
Depuy, Inc.
Orthopedic
94d
Cleared
Mar 27, 1984
POROCOAT HPS II HIP PROSTHESIS
Depuy, Inc.
Orthopedic
147d
Cleared
Mar 02, 1984
POROCOAT NEB TOTAL HIP SYSTEM
Depuy, Inc.
Orthopedic
149d
Cleared
Jan 27, 1984
POROCOAT SCHATZKER ACETABULUM
Depuy, Inc.
Orthopedic
114d