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..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
361–384 of 564
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 Apr 06, 2000
ESKA MODULAR HIP SYSTEM
K993027
Specs USA, Inc.
Orthopedic · 210d
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
Cleared Dec 22, 1999
MODULAR REACH HIP
K994038
Biomet, Inc.
Orthopedic · 23d
Cleared Dec 20, 1999
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS)
K990849
Howmedica Osteonics Corp.
Orthopedic · 280d
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
K993082
Exactech, Inc.
Orthopedic · 65d
Cleared Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109
Encore Orthopedics, Inc.
Orthopedic · 51d
Cleared Jul 12, 1999
TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
K990135
Zimmer, Inc.
Orthopedic · 180d
Cleared Jul 12, 1999
SYNERGY POROUS SIZE 8 HIP STEM
K991485
Smith & Nephew, Inc.
Orthopedic · 75d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807
Biomet, Inc.
Orthopedic · 43d
Cleared Jul 01, 1999
HEDROCEL ACETABULAR CAGE SYSTEM
K983837
Implex Corp.
Orthopedic · 244d