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
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
Apr 22, 2021
Restoration Anatomic Shell
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic
28d
Cleared
Feb 10, 2021
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
Encore Medical, L.P.
Orthopedic
65d
Cleared
Oct 21, 2020
ACTIS Duofix Hip Prosthesis
DePuy Orthopaedics, Inc.
Orthopedic
54d
Cleared
Sep 24, 2020
Cordera Hip System
Conformis, Inc.
Orthopedic
24d
Cleared
Sep 11, 2020
DePuy PINNACLE Dual Mobility Liner
Depuy Ireland UC
Orthopedic
164d
Cleared
Aug 14, 2020
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
Signature Orthopaedics Pty, Ltd.
Orthopedic
415d
Cleared
Jul 08, 2020
Delta Multihole TT Pro Acetabular System
Lima Corporate S.P.A.
Orthopedic
118d
Cleared
May 27, 2020
Restoration® Modular Hip System
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
Orthopedic
184d
Cleared
May 14, 2020
KeYi Total Hip System
Beijing Keyi Medical Device Technology Co., Ltd.
Orthopedic
311d
Cleared
Dec 17, 2019
Precision Casting Solutions Total Hip System
Precision Casting Solution, LLC
Orthopedic
102d
Cleared
Dec 06, 2019
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
Zimmer, Inc.
Orthopedic
267d
Cleared
Dec 05, 2019
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
Zimmer, Inc.
Orthopedic
266d
Cleared
Nov 26, 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
DePuy Orthopaedics, Inc.
Orthopedic
42d
Cleared
Nov 06, 2019
Conformis Hip System
Conformis, Inc.
Orthopedic
85d
Cleared
Nov 05, 2019
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
Zimmer, Inc.
Orthopedic
327d
Cleared
Nov 01, 2019
Delta Multihole TT Pro Acetabular System
Lima Corporate S.P.A.
Orthopedic
136d
Cleared
Oct 31, 2019
OR3O Dual Mobility System
Smith & Nephew, Inc.
Orthopedic
198d
Cleared
Oct 25, 2019
REDAPT Blade Augments
Smith & Nephew, Inc.
Orthopedic
207d
Cleared
Oct 24, 2019
Trident II Acetabular System
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic
156d
Cleared
Aug 30, 2019
iNSitu Total Hip System
Theken Companies, LLC
Orthopedic
28d