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
241–264 of 565
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 Apr 16, 2007
POLARCUP DUAL MOBILITY SYSTEM
K070278
Plus Orthopedics AG
Orthopedic · 77d
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
Cleared Nov 15, 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
K062419
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Oct 24, 2006
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
K062148
DePuy Orthopaedics, Inc.
Orthopedic · 89d
Cleared Aug 24, 2006
MONOBLOCK PRESS-FIT HIP STEM
K060072
Omni Life Science, Inc.
Orthopedic · 227d
Cleared Aug 22, 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Aug 02, 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226
Zimmer, Inc.
Orthopedic · 92d
Cleared Jul 24, 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786
Zimmer, Inc.
Orthopedic · 28d
Cleared Jul 20, 2006
M-COR HIP REPLACEMENT SYSTEM
K053417
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 224d
Cleared Jul 18, 2006
ORTHOPEDIC SOURCE PRESS-FIT HIP
K061124
Orthopedic Source, Inc.
Orthopedic · 85d
Cleared Jul 18, 2006
PCA 36MM FEMORAL HEADS
K061168
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Jul 17, 2006
DEPUY AML HIP PROSTHESIS
K061833
DePuy Orthopaedics, Inc.
Orthopedic · 18d
Cleared Jul 03, 2006
DYNASTY ACETABULAR SHELL
K061547
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jun 14, 2006
REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING
K060630
Smith & Nephew, Inc.
Orthopedic · 97d
Cleared May 25, 2006
TRABECULAR METAL ACETABULAR AUGMENTS
K061067
Zimmer Trabecular
Orthopedic · 38d
Cleared May 19, 2006
DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K060581
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 12, 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040
Zimmer, Inc.
Orthopedic · 126d
Cleared Apr 28, 2006
POROUS TITANIUM ACETABULAR SHELLS
K052996
Biomet Manufacturing Corp
Orthopedic · 185d