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