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..

562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
265–288 of 562
Cleared Aug 31, 2000
LINEAGE ACETABULAR SYSTEM
K002149
Wrightmedicaltechnologyinc
Orthopedic · 45d
Cleared Aug 25, 2000
TITAN POROCOAT HIP PROSTHESIS
K001991
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Jul 26, 2000
TRI-LOCK HIP STEM
K001982
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 15, 2000
THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
K001039
Implex Corp.
Orthopedic · 76d
Cleared Jun 14, 2000
MALLORY HEAD MODULAR CALCAR
K001660
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Jun 12, 2000
PINNACLE ACETABULAR SYSTEM
K001534
DePuy Orthopaedics, Inc.
Orthopedic · 26d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760
Biomet, Inc.
Orthopedic · 76d
Cleared May 10, 2000
KEYSTONE HIP
K000521
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared Apr 11, 2000
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS
K990830
Biomet, Inc.
Orthopedic · 396d
Cleared Apr 10, 2000
HEMISPHERE MODULAR CUP SYSTEM
K000321
Ortho Development Corp.
Orthopedic · 68d
Cleared Apr 06, 2000
BICON-PLUS ACETABULAR COMPONENTS
K992154
Plus Orthopedics
Orthopedic · 286d
Cleared Mar 23, 2000
PINNACLE ACETABULAR SYSTEM
K000306
DePuy Orthopaedics, Inc.
Orthopedic · 51d
Cleared Mar 15, 2000
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
K000538
Biomet, Inc.
Orthopedic · 27d
Cleared Mar 10, 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259
Sulzer Orthopedics, Inc.
Orthopedic · 163d
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286
Zimmer, Inc.
Orthopedic · 81d
Cleared Feb 25, 2000
MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
K000335
Biomet, Inc.
Orthopedic · 22d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334
Biomet, Inc.
Orthopedic · 13d
Cleared Feb 04, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K000207
DePuy Orthopaedics, Inc.
Orthopedic · 11d
Cleared Feb 03, 2000
MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS
K994415
DePuy Orthopaedics, Inc.
Orthopedic · 36d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736
Exactech, Inc.
Orthopedic · 77d
Cleared Jan 20, 2000
REVELATION POROUS HIP STEM
K994070
Encore Orthopedics, Inc.
Orthopedic · 49d