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 Smith & Nephew, Inc., Howmedica Osteonics Corp., Dba Stryker Orthopaedics and Depuy Ireland UC.
559
Total
559
Cleared
151d
Avg days
1984
Since
559 devices
Cleared
Apr 14, 2023
LINK MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG
Orthopedic
275d
Cleared
Feb 27, 2023
BENCOX Mirabo Z Cup Cortinium
Corentec Co., Ltd.
Orthopedic
133d
Cleared
Jan 10, 2023
CoCr Head
Zimmer GmbH
Orthopedic
642d
Cleared
Nov 04, 2022
United U2 femoral head, 22mm delta ceramic head
United Orthopedic Corporation
Orthopedic
148d
Cleared
Oct 03, 2022
ONVOY Acetabular System
Globus Medical, Inc.
Orthopedic
298d
Cleared
Sep 06, 2022
EMPHASYS Acetabular System
Depuy Ireland UC
Orthopedic
92d
Cleared
Aug 18, 2022
OR3O Dual Mobility System
Smith & Nephew, Inc.
Orthopedic
139d
Cleared
Jul 01, 2022
Smith & Nephew Hip Systems
Smith & Nephew, Inc.
Orthopedic
437d
Cleared
May 24, 2022
BENCOX Mirabo Z Cup Cortinium
Corentec Co., Ltd.
Orthopedic
449d
Cleared
May 18, 2022
BENCOX Mirabo Cup System
Corentec Co., Ltd.
Orthopedic
90d
Cleared
Mar 09, 2022
Acetabular Dome Hole Plug
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
27d
Cleared
Mar 01, 2022
Restoration® Modular Hip System
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
231d
Cleared
Jan 19, 2022
R3 Large Head Liners
Smith & Nephew, Inc.
Orthopedic
261d
Cleared
Dec 20, 2021
Mpact® 3D Metal Implants - DMLS Technology
Medacta International S.A.
Orthopedic
472d
Cleared
Oct 01, 2021
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
Microport Orthopedics, Inc.
Orthopedic
638d
Cleared
Jul 14, 2021
Provident II Hip Stems
Globus Medical, Inc.
Orthopedic
384d
Cleared
Jul 14, 2021
Bencox THR System
Corentec Co., Ltd.
Orthopedic
28d
Cleared
May 28, 2021
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
Waldemar Link GmbH & Co. KG
Orthopedic
445d
Cleared
Apr 28, 2021
MPACT Extension
Medacta International S.A.
Orthopedic
435d
Cleared
Feb 10, 2021
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
Encore Medical, L.P.
Orthopedic
65d