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 Smith & Nephew, Inc., Howmedica Osteonics Corp., Dba Stryker Orthopaedics and Depuy Ireland UC.

559
Total
559
Cleared
151d
Avg days
1984
Since
559 devices
25–48 of 559
Cleared Apr 14, 2023
LINK MobileLink Acetabular Cup System
K222066
Waldemar Link GmbH & Co. KG
Orthopedic · 275d
Cleared Feb 27, 2023
BENCOX Mirabo Z Cup Cortinium
K223223
Corentec Co., Ltd.
Orthopedic · 133d
Cleared Jan 10, 2023
CoCr Head
K211047
Zimmer GmbH
Orthopedic · 642d
Cleared Nov 04, 2022
United U2 femoral head, 22mm delta ceramic head
K221675
United Orthopedic Corporation
Orthopedic · 148d
Cleared Oct 03, 2022
ONVOY Acetabular System
K213842
Globus Medical, Inc.
Orthopedic · 298d
Cleared Sep 06, 2022
EMPHASYS Acetabular System
K221636
Depuy Ireland UC
Orthopedic · 92d
Cleared Aug 18, 2022
OR3O Dual Mobility System
K220959
Smith & Nephew, Inc.
Orthopedic · 139d
Cleared Jul 01, 2022
Smith & Nephew Hip Systems
K211176
Smith & Nephew, Inc.
Orthopedic · 437d
Cleared May 24, 2022
BENCOX Mirabo Z Cup Cortinium
K210614
Corentec Co., Ltd.
Orthopedic · 449d
Cleared May 18, 2022
BENCOX Mirabo Cup System
K220468
Corentec Co., Ltd.
Orthopedic · 90d
Cleared Mar 09, 2022
Acetabular Dome Hole Plug
K220376
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 27d
Cleared Mar 01, 2022
Restoration® Modular Hip System
K212187
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 231d
Cleared Jan 19, 2022
R3 Large Head Liners
K211330
Smith & Nephew, Inc.
Orthopedic · 261d
Cleared Dec 20, 2021
Mpact® 3D Metal Implants - DMLS Technology
K202568
Medacta International S.A.
Orthopedic · 472d
Cleared Oct 01, 2021
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
K200011
Microport Orthopedics, Inc.
Orthopedic · 638d
Cleared Jul 14, 2021
Provident II Hip Stems
K201733
Globus Medical, Inc.
Orthopedic · 384d
Cleared Jul 14, 2021
Bencox THR System
K211866
Corentec Co., Ltd.
Orthopedic · 28d
Cleared May 28, 2021
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
K200607
Waldemar Link GmbH & Co. KG
Orthopedic · 445d
Cleared Apr 28, 2021
MPACT Extension
K200391
Medacta International S.A.
Orthopedic · 435d
Cleared Feb 10, 2021
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
K203557
Encore Medical, L.P.
Orthopedic · 65d