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..

562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
409–432 of 562
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
Cleared Jul 02, 1992
BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM
K921639
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 22, 1990
ACCESS(TM), SOFTWARE RELEASE 4.11P
K896637
Diasonics, Inc.
Radiology · 59d
Cleared Jul 30, 1986
TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
K862702
Depuy, Inc.
Orthopedic · 15d
Cleared Jul 16, 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326
Johnson & Johnson Professionals, Inc.
Orthopedic · 27d
Cleared May 06, 1986
PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
K860442
Howmedica Corp.
Orthopedic · 91d
Cleared Mar 14, 1986
OPTI-FIX TOTAL HIP SYSTEM
K860635
Richards Medical Co., Inc.
Orthopedic · 22d
Cleared Aug 22, 1985
AML PROXIMAL POROCOAT FEMORAL HIP
K852198
Depuy, Inc.
Orthopedic · 94d
Cleared Mar 27, 1984
POROCOAT HPS II HIP PROSTHESIS
K833681
Depuy, Inc.
Orthopedic · 147d
Cleared Mar 02, 1984
POROCOAT NEB TOTAL HIP SYSTEM
K833439
Depuy, Inc.
Orthopedic · 149d
Cleared Jan 27, 1984
POROCOAT SCHATZKER ACETABULUM
K833464
Depuy, Inc.
Orthopedic · 114d