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 DePuy Orthopaedics, Inc..

561
Total
561
Cleared
152d
Avg days
1984
Since
561 devices
25–48 of 561
Cleared Sep 20, 2023
Mpact Extension
K230011
Medacta International S.A.
Orthopedic · 260d
Cleared Sep 20, 2023
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System
K232556
Depuy Ireland UC
Orthopedic · 28d
Cleared May 09, 2023
Latitud™ Hip Replacement System
K222436
Meril Healthcare Pvt. , Ltd.
Orthopedic · 270d
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 Feb 13, 2023
EMPOWR™ blade stem
K223779
Encore Medical, LLC
Orthopedic · 59d
Cleared Jan 30, 2023
My3D® Personalized Pelvic Reconstruction
K223348
Onkos Surgical, Inc.
Orthopedic · 89d
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 30, 2022
Mg-PSZ Ceramic Femoral Head
K220336
Theken Companies
Orthopedic · 235d
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 06, 2022
My3D® Personalized Pelvic Reconstruction
K212815
Onkos Surgical
Orthopedic · 306d
Cleared Jul 01, 2022
Smith & Nephew Hip Systems
K211176
Smith & Nephew, Inc.
Orthopedic · 437d
Cleared Jun 16, 2022
DePuy 3D Additive TriFlange Acetabular Cup
K201348
Depuy International, Ltd.
Orthopedic · 756d
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 May 17, 2022
Biocore9 Acetabular Cup System
K212761
Biocore9, LLC
Orthopedic · 259d
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