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 DePuy Orthopaedics, Inc..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
97–120 of 561
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790
Smith & Nephew, Inc.
Orthopedic · 236d
Cleared Oct 06, 2015
Arcos One-piece Femoral Revision System
K151603
Biomet, Inc.
Orthopedic · 116d
Cleared Aug 13, 2015
Continuum and Trilogy Integrated Taper (IT) Acetabular Systems
K151448
Zimmer, Inc.
Orthopedic · 76d
Cleared May 01, 2015
G7 Dual Mobility System
K150522
Biomet, Inc.
Orthopedic · 60d
Cleared Mar 25, 2015
Echo Bi-Metric Microplasty Line Extension
K150503
Biomet, Inc.
Orthopedic · 27d
Cleared Feb 10, 2015
G7 Freedom and Offset Liners, Freedom Head, Size 32
K142882
Biomet, Inc.
Orthopedic · 131d
Cleared Dec 18, 2014
Echo Bi-Metric Microplasty Hip System
K143009
Biomet, Inc.
Orthopedic · 59d
Cleared Dec 11, 2014
G7 OSSEOTI ACETUBLAR SHELLS
K140669
Biomet, Inc.
Orthopedic · 268d
Cleared Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959
DePuy Orthopaedics, Inc.
Orthopedic · 171d
Cleared Apr 19, 2013
ARCOS TROCHANTER BUTTON
K130063
Biomet, Inc.
Orthopedic · 99d
Cleared Oct 24, 2012
SMITH & NEPHEW SMF HIP STEM
K123012
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Oct 22, 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019
Zimmer, Inc.
Orthopedic · 24d
Cleared Sep 14, 2012
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
K113296
Zimmer, Inc.
Orthopedic · 311d
Cleared Aug 23, 2012
POLARCUP DUAL MOBILITY SYSTEM
K122244
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jul 30, 2012
HIP SYSTEMS
K121308
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Oct 14, 2011
POLARCUP DUAL MOBILITY SYSTEM
K110135
Smith & Nephew, Inc.
Orthopedic · 269d
Cleared Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662
Zimmer, Inc.
Orthopedic · 121d
Cleared Apr 11, 2011
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072
Howmedica Osteonics Corp.
Orthopedic · 357d
Cleared Jan 31, 2011
SMITH & NEPHEW SMF HIP STEM
K103256
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
K101229
Zimmer, Inc.
Orthopedic · 214d
Cleared Oct 29, 2010
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K102423
DePuy Orthopaedics, Inc.
Orthopedic · 65d
Cleared Apr 28, 2010
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K093561
Zimmer, Inc.
Orthopedic · 161d
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