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..
564
Total
564
Cleared
152d
Avg days
1984
Since
564 devices
Cleared
Feb 15, 2024
EMPHASYS™ Dual Mobility System
Depuy Ireland UC
Orthopedic
265d
Cleared
Dec 21, 2023
Stryker Orthopaedics Hip Systems Labeling Update
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic
51d
Cleared
Oct 27, 2023
OR3O Dual Mobility Liners
Smith & Nephew, Inc.
Orthopedic
56d
Cleared
Sep 20, 2023
Mpact Extension
Medacta International S.A.
Orthopedic
260d
Cleared
Sep 20, 2023
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
Depuy Ireland UC
Orthopedic
28d
Cleared
May 09, 2023
Latitud™ Hip Replacement System
Meril Healthcare Pvt. , Ltd.
Orthopedic
270d
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
Feb 13, 2023
EMPOWR™ blade stem
Encore Medical, LLC
Orthopedic
59d
Cleared
Jan 30, 2023
My3D® Personalized Pelvic Reconstruction
Onkos Surgical, Inc.
Orthopedic
89d
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 30, 2022
Mg-PSZ Ceramic Femoral Head
Theken Companies
Orthopedic
235d
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 06, 2022
My3D® Personalized Pelvic Reconstruction
Onkos Surgical
Orthopedic
306d
Cleared
Jul 01, 2022
Smith & Nephew Hip Systems
Smith & Nephew, Inc.
Orthopedic
437d
Cleared
Jun 16, 2022
DePuy 3D Additive TriFlange Acetabular Cup
Depuy International, Ltd.
Orthopedic
756d
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
May 17, 2022
Biocore9 Acetabular Cup System
Biocore9, LLC
Orthopedic
259d
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