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..

562
Total
562
Cleared
152d
Avg days
1984
Since
562 devices
97–120 of 562
Cleared Jul 17, 2017
U2 Femoral Head
K162957
United Orthopedic Corporation
Orthopedic · 266d
Cleared Jun 26, 2017
PROCOTYL® PRIME Acetabular Cup System
K170444
Microport Orthopedics, Inc.
Orthopedic · 132d
Cleared Jun 14, 2017
iTotal® Hip Replacement System
K162719
Conformis, Inc.
Orthopedic · 258d
Cleared Jun 08, 2017
UTF Stem, reduced, #0, #00
K163193
United Orthopedic Corporation
Orthopedic · 205d
Cleared May 26, 2016
G7 Dual Mobility System, Active Articulation System
K161190
Biomet, Inc.
Orthopedic · 29d
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 Sep 03, 2015
Exactech® Novation® Crown Cup®
K141960
Exactech, Inc.
Orthopedic · 412d
Cleared Aug 13, 2015
U2 Hip Stem, Ti Porous Coated, Matrix
K151316
United Orthopedic Corporation
Orthopedic · 87d
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 Mar 02, 2015
Mpact Double Mobility System
K143453
Medacta International
Orthopedic · 89d
Cleared Feb 27, 2015
PROCOTYL L-O ACETABULAR SYSTEM
K142119
Microport Orthopedics, Inc.
Orthopedic · 207d
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 Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797
Exactech, Inc.
Orthopedic · 27d
Cleared Jun 30, 2014
DELTA TT ACETABULAR SYSTEM
K141395
Lima Corporate S.P.A.
Orthopedic · 33d
Cleared Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
K132697
Ortho Development Corp.
Orthopedic · 295d
Cleared Mar 11, 2014
OVATION TRIBUTE HIP STEM
K133386
Ortho Development Corp.
Orthopedic · 126d
Cleared Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959
DePuy Orthopaedics, Inc.
Orthopedic · 171d
Cleared Jan 22, 2014
MPACT EXTENSION
K132879
Medacta International
Orthopedic · 131d
Cleared Oct 16, 2013
OVATION 10/12 HIP STEM
K131022
Ortho Development Corp.
Orthopedic · 187d