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..

564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
121–144 of 564
Cleared Sep 03, 2015
Klassic HD Hip System
K151440
Total Joint Orthopedics, Inc.
Orthopedic · 97d
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 Aug 10, 2015
Restoration Anatomic Shell
K151264
Stryker Orthopaedics
Orthopedic · 89d
Cleared May 04, 2015
Modified Bencox Hip System
K150007
Corentec Co., Ltd.
Orthopedic · 122d
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 27, 2015
Progressive Orthopaedic Total Hip System
K143314
The Progressive Orthopaedic Company, LLC
Orthopedic · 100d
Cleared Feb 10, 2015
G7 Freedom and Offset Liners, Freedom Head, Size 32
K142882
Biomet, Inc.
Orthopedic · 131d
Cleared Feb 09, 2015
Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
K143085
Stryker Orthopaedics
Orthopedic · 105d
Cleared Jan 26, 2015
OMNI Interface Acetabular System
K142201
Omnlife Science
Orthopedic · 168d
Cleared Jan 26, 2015
Trident® Tritanium® PST® Acetabular Shells
K142606
Mako Surgical Corp.
Orthopedic · 133d
Cleared Jan 22, 2015
EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM
K140547
Excera Orthopedics, Inc.
Orthopedic · 324d
Cleared Dec 29, 2014
G7 Finned Acetabular Shell
K142746
Biomet Manufactuting Corp.
Orthopedic · 96d
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 Nov 14, 2014
Restoration Anatomic Shell
K142462
Stryker Orthopaedics
Orthopedic · 73d
Cleared Nov 04, 2014
RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM
K141676
Renovis Surgical Technologies, Inc.
Orthopedic · 134d
Cleared Jul 30, 2014
ALPINE HIP STEM
K141001
Ortho Development
Orthopedic · 103d
Cleared Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797
Exactech, Inc.
Orthopedic · 27d
Cleared Jul 22, 2014
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
K133370
Signature Orthopaedics Pty Limited
Orthopedic · 260d
Cleared Jun 30, 2014
DELTA TT ACETABULAR SYSTEM
K141395
Lima Corporate S.P.A.
Orthopedic · 33d