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
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
Apr 16, 2007
POLARCUP DUAL MOBILITY SYSTEM
Plus Orthopedics AG
Orthopedic
77d
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
Cleared
Nov 15, 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
Howmedica Osteonics Corp.
Orthopedic
89d
Cleared
Oct 24, 2006
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
DePuy Orthopaedics, Inc.
Orthopedic
89d
Cleared
Aug 24, 2006
MONOBLOCK PRESS-FIT HIP STEM
Omni Life Science, Inc.
Orthopedic
227d
Cleared
Aug 22, 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
Howmedica Osteonics Corp.
Orthopedic
90d
Cleared
Aug 02, 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
Zimmer, Inc.
Orthopedic
92d
Cleared
Jul 24, 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
28d
Cleared
Jul 20, 2006
M-COR HIP REPLACEMENT SYSTEM
Portland Orthopaedics Pty. , Ltd.
Orthopedic
224d
Cleared
Jul 18, 2006
ORTHOPEDIC SOURCE PRESS-FIT HIP
Orthopedic Source, Inc.
Orthopedic
85d
Cleared
Jul 18, 2006
PCA 36MM FEMORAL HEADS
Howmedica Osteonics Corp.
Orthopedic
82d
Cleared
Jul 17, 2006
DEPUY AML HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
18d
Cleared
Jul 03, 2006
DYNASTY ACETABULAR SHELL
Wrightmedicaltechnologyinc
Orthopedic
28d
Cleared
Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
Smith & Nephew, Inc.
Orthopedic
97d
Cleared
May 25, 2006
TRABECULAR METAL ACETABULAR AUGMENTS
Zimmer Trabecular
Orthopedic
38d
Cleared
May 19, 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
DePuy Orthopaedics, Inc.
Orthopedic
73d
Cleared
May 12, 2006
ZIMMER M/L TAPER HIP PROSTHESIS
Zimmer, Inc.
Orthopedic
126d
Cleared
Apr 28, 2006
POROUS TITANIUM ACETABULAR SHELLS
Biomet Manufacturing Corp
Orthopedic
185d