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
217–240 of 564
Cleared Apr 28, 2010
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K093561
Zimmer, Inc.
Orthopedic · 161d
Cleared Mar 29, 2010
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
K100555
Omni Life Science, Inc.
Orthopedic · 28d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098
Smith & Nephew, Inc.
Orthopedic · 192d
Cleared Oct 23, 2009
TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
K090897
Howmedica Osteonics Corp.
Orthopedic · 205d
Cleared Oct 23, 2009
INTERFACE ACETABULAR CUP LINERS
K092443
Omni Life Science, Inc.
Orthopedic · 74d
Cleared Sep 11, 2009
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM
K091508
Zimmer, Inc.
Orthopedic · 112d
Cleared Aug 21, 2008
SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
K081566
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Aug 20, 2008
REVELATION HIP STEM, MODELS, 427-01, 427-02
K081679
Encore Medical, L.P.
Orthopedic · 64d
Cleared Jul 22, 2008
TRITANIUM ACETABULAR SHELL SYSTEM
K081171
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared May 15, 2008
ECHELON TITANIUM HIP SYSTEM
K072817
Smith & Nephew, Inc.
Orthopedic · 226d
Cleared May 08, 2008
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE
K080625
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Feb 27, 2008
APEX-LNK POLY ACETABULAR CUP LINERS
K073150
Omni Life Science, Inc.
Orthopedic · 111d
Cleared Jan 10, 2008
SMITH & NEPHEW MIS HIP STEM
K072417
Smith & Nephew, Inc.
Orthopedic · 135d
Cleared Jan 10, 2008
REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
K072888
Encore Medical, L.P.
Orthopedic · 92d
Cleared Jan 09, 2008
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963
DePuy Orthopaedics, Inc.
Orthopedic · 82d
Cleared Dec 14, 2007
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154
Encore Medical, L.P.
Orthopedic · 133d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160
Smith & Nephew, Inc.
General & Plastic Surgery · 162d
Cleared Jul 25, 2007
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784
DePuy Orthopaedics, Inc.
Orthopedic · 23d
Cleared May 23, 2007
VITALITY HIP SYSTEM MODEL#420
K070050
Encore Medical, L.P.
Orthopedic · 139d
Cleared Mar 09, 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369
Biomet, Inc.
Orthopedic · 29d
Cleared Jan 25, 2007
MODIFICATION TO HIPSTAR FEMORAL STEM
K063822
Stryker Orthopaedics
Orthopedic · 30d
Cleared Jan 16, 2007
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
K062775
Ortho Development Corp.
Orthopedic · 120d
Cleared Dec 20, 2006
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
K061461
Zimmer, Inc.
Orthopedic · 208d
Cleared Nov 22, 2006
FMP COATED SPIKED ACETABULAR CUP
K063257
Encore Medical, L.P.
Orthopedic · 26d