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