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..

565
Total
565
Cleared
152d
Avg days
1984
Since
565 devices
217–240 of 565
Cleared Sep 14, 2010
INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET
K101976
Omni Life Science, Inc.
Orthopedic · 63d
Cleared Jun 30, 2010
APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
K101575
Omnlife Science
Orthopedic · 23d
Cleared May 27, 2010
NOVATION CROWN CUP GXL LINERS
K100269
Exactech, Inc.
Orthopedic · 118d
Cleared Apr 28, 2010
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K093561
Zimmer, Inc.
Orthopedic · 161d
Cleared Apr 22, 2010
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
K094045
Cardo Medical Corp.
Orthopedic · 112d
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 10, 2008
ACCIN HIP SYSTEM
K073068
Accelerated Innovation, LLC
Orthopedic · 72d
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 Nov 19, 2007
RIGI-FIX HIP STEM SYSTEM
K072101
Implants Intl. , Ltd.
Orthopedic · 111d
Cleared Oct 05, 2007
REFLECTION, TANDEM UNIPOLAR
K071160
Smith & Nephew, Inc.
General & Plastic Surgery · 162d
Cleared Aug 15, 2007
APEX HCLA ACETABULAR CUP LINERS
K062489
Omnilife Science
Orthopedic · 355d