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..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
73–96 of 561
Cleared Aug 28, 2019
Conformis BeneFIT Hip System
K190904
Conformis, Inc.
Orthopedic · 142d
Cleared Aug 20, 2019
iNSitu Total Hip System
K191936
Thecken Companies, LLC
Orthopedic · 32d
Cleared Jul 26, 2019
Medtronic Total Hip Arthroplasty System
K183129
Medtronic Advanced Energy
Orthopedic · 255d
Cleared Jul 15, 2019
MicroPort CoCr Femoral Heads
K190123
Microport Orthopedics, Inc.
Orthopedic · 171d
Cleared Jun 07, 2019
DJO Acetabular System
K190057
Encore Medical, L.P.
Orthopedic · 147d
Cleared May 31, 2019
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
K182678
Zimmer, Inc.
Orthopedic · 247d
Cleared Apr 01, 2019
Bencox Mirabo Cup Multi Hole
K182221
Corentec Co., Ltd.
Orthopedic · 228d
Cleared Mar 21, 2019
MPACT Extension
K183582
Medacta International S.A.
Orthopedic · 90d
Cleared Mar 19, 2019
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
K182468
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic · 190d
Cleared Mar 13, 2019
Alteon Acetabular Cup System
K182502
Exactech, Inc.
Orthopedic · 182d
Cleared Mar 08, 2019
Provident II Hip Stem
K190276
Stelkast, Inc.
Orthopedic · 28d
Cleared Dec 26, 2018
Delta TT Pro
K182099
Lima Corporate S.P.A.
Orthopedic · 145d
Cleared Nov 16, 2018
REDAPT Modular Acetabular Shell
K182109
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Sep 24, 2018
REDAPT Porous Acetabular Shell
K181366
Smith & Nephew, Inc.
Orthopedic · 124d
Cleared Jul 19, 2018
Latitud Hip Replacement System
K172857
Meril Healthcare Pvt. , Ltd.
Orthopedic · 302d
Cleared Jul 09, 2018
Prime Acetabular Cup System
K180798
Microport Orthopedics, Inc.
Orthopedic · 104d
Cleared Jun 15, 2018
Trinity PLUS Acetabular Shell
K172551
Corin U.S.A. Limited
Orthopedic · 296d
Cleared May 30, 2018
Legend Acetabular Liners
K173951
Ortho Development Corporation
Orthopedic · 154d
Cleared Mar 27, 2018
Mpact® 3D Metal™ Implants and Augments 3D Metal™
K171966
Medacta International S.A.
Orthopedic · 270d
Cleared Jan 04, 2018
Bone Screws 6.5mm
K172456
Lima Corporate S.P.A.
Orthopedic · 143d
Cleared Nov 30, 2017
Birmingham Hip (BH) Dual Mobility Insert
K171934
Smith & Nephew, Inc.
Orthopedic · 155d
Cleared Nov 21, 2017
Smith & Nephew, Inc. REDAPT Augments
K171073
Smith & Nephew, Inc.
Orthopedic · 224d
Cleared Oct 03, 2017
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
K172684
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared May 26, 2016
G7 Dual Mobility System, Active Articulation System
K161190
Biomet, Inc.
Orthopedic · 29d