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
49–72 of 561
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 Apr 22, 2021
Restoration Anatomic Shell
K210893
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic · 28d
Cleared Feb 10, 2021
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing
K203557
Encore Medical, L.P.
Orthopedic · 65d
Cleared Oct 21, 2020
ACTIS Duofix Hip Prosthesis
K202472
DePuy Orthopaedics, Inc.
Orthopedic · 54d
Cleared Sep 24, 2020
Cordera Hip System
K202484
Conformis, Inc.
Orthopedic · 24d
Cleared Sep 11, 2020
DePuy PINNACLE Dual Mobility Liner
K200854
Depuy Ireland UC
Orthopedic · 164d
Cleared Aug 14, 2020
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
K191708
Signature Orthopaedics Pty, Ltd.
Orthopedic · 415d
Cleared Jul 08, 2020
Delta Multihole TT Pro Acetabular System
K200656
Lima Corporate S.P.A.
Orthopedic · 118d
Cleared May 27, 2020
Restoration® Modular Hip System
K193233
Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)
Orthopedic · 184d
Cleared May 14, 2020
KeYi Total Hip System
K191826
Beijing Keyi Medical Device Technology Co., Ltd.
Orthopedic · 311d
Cleared Dec 17, 2019
Precision Casting Solutions Total Hip System
K192450
Precision Casting Solution, LLC
Orthopedic · 102d
Cleared Dec 06, 2019
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
K190656
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
K190660
Zimmer, Inc.
Orthopedic · 266d
Cleared Nov 26, 2019
Pinnacle Duofix HA Acetabular Cup Prosthesis
K192919
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Nov 06, 2019
Conformis Hip System
K192198
Conformis, Inc.
Orthopedic · 85d
Cleared Nov 05, 2019
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
K183457
Zimmer, Inc.
Orthopedic · 327d
Cleared Nov 01, 2019
Delta Multihole TT Pro Acetabular System
K191622
Lima Corporate S.P.A.
Orthopedic · 136d
Cleared Oct 31, 2019
OR3O Dual Mobility System
K191002
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 25, 2019
REDAPT Blade Augments
K190847
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 24, 2019
Trident II Acetabular System
K191358
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Orthopedic · 156d
Cleared Aug 30, 2019
iNSitu Total Hip System
K192071
Theken Companies, LLC
Orthopedic · 28d