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
Stable submission activity - 20 submissions in the last 2 years
Review times increasing: avg 187d recently vs 151d historically

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented Devices (Product Code LPH)

561 devices
1–24 of 561
Cleared Jun 05, 2026
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
K243192
Nextstep Arthopedix, LLC
Orthopedic · 613d
Cleared May 19, 2026
Taperloc® Complete Hip Stem
K251270
Biomet, Inc.
Orthopedic · 390d
Cleared Feb 04, 2026
G7® Revision Acetabular System
K252623
Zimmer, Inc.
Orthopedic · 169d
Cleared Jan 28, 2026
Mpact 3D Metal Implants Extension – DMLS Technology
K251043
Medacta International S.A.
Orthopedic · 300d
Cleared Dec 05, 2025
Velora Acetabular System
K252067
Restor3D, Inc.
Orthopedic · 157d
Cleared Nov 20, 2025
TaperSet™ Hip System
K252846
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
Orthopedic · 73d
Cleared Nov 12, 2025
EMPOWR Acetabular® Liner Extension
K251833
Encore Medical, L.P.
Orthopedic · 149d
Cleared Aug 29, 2025
ArTT Augments and Buttresses and Bone Screws
K251718
Lima Corporate S.P.A.
Orthopedic · 86d
Cleared Jul 25, 2025
Stryker and Serf hip devices
K250989
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 116d
Cleared Jun 06, 2025
ONVOY™ Acetabular System
K243456
Globus Medical, Inc.
Orthopedic · 211d
Cleared Jun 05, 2025
Trinity EVO Acetabular Shell
K242744
Corin U.S.A. Limited
Orthopedic · 267d
Cleared Apr 23, 2025
Mpact 3D Metal Augments II
K242232
Medacta International S.A.
Orthopedic · 267d
Cleared Apr 10, 2025
Initia T3 Acetabular Hemispherical Shell System
K242045
Kyocera Medical Technologies, Inc.
Orthopedic · 272d
Cleared Feb 06, 2025
Stryker Orthopaedics Hip Devices Labeling Update
K243784
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 59d
Cleared Jan 22, 2025
EMPHASYS Acetabular System
K243977
Depuy Ireland UC
Orthopedic · 30d
Cleared Jan 13, 2025
Pantheon Proximal Femur Reconstruction (PFR) System
K241059
Adler Ortho S.P.A
Orthopedic · 270d
Cleared Nov 08, 2024
MobileLink Acetabular Cup System - Line Extension (Multiple)
K241636
Waldemar Link GmbH & Co. KG
Orthopedic · 155d
Cleared Oct 11, 2024
Legend® Acetabular Shell
K242833
Ortho Development Corp.
Orthopedic · 22d
Cleared Oct 07, 2024
EMPHASYS Acetabular Shell with RapiTite HA
K242084
Depuy Ireland UC
Orthopedic · 83d
Cleared Oct 07, 2024
OR3O Dual Mobility System
K242375
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Apr 18, 2024
Ethylene Oxide Sterilization Supplier Change for MPO Hips
K240046
Microport Orthopedics
Orthopedic · 101d
Cleared Feb 15, 2024
EMPHASYS™ Dual Mobility System
K231522
Depuy Ireland UC
Orthopedic · 265d
Cleared Dec 21, 2023
Stryker Orthopaedics Hip Systems Labeling Update
K233498
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Orthopedic · 51d
Cleared Oct 27, 2023
OR3O Dual Mobility Liners
K232667
Smith & Nephew, Inc.
Orthopedic · 56d

About Product Code LPH - Regulatory Context

510(k) Submission Activity

561 total 510(k) submissions under product code LPH since 1984, with 561 receiving FDA clearance (average review time: 152 days).

Submission volume has remained relatively stable over the observed period, with 20 submissions in the last 24 months.

FDA 510(k) Review Time - LPH Product Code

Recent submissions under LPH have taken an average of 187 days to reach a decision - up from 151 days historically. Manufacturers should account for longer review timelines in current project planning.

LPH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →