LPH · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Orthopedic · 21 CFR 888.3358 · Class 2
Overview
| Product Code | LPH |
|---|---|
| Device Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 559)
Showing 20 most recent of 559 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | Feb 4, 2026 | SESE |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | Jan 28, 2026 | SESE |
| K252067 | Velora Acetabular System | Restor3D, Inc. | Dec 5, 2025 | SESE |
| K252846 | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | Nov 20, 2025 | SESE |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | Nov 12, 2025 | SESE |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | Aug 29, 2025 | SESE |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | Jul 25, 2025 | SESE |
| K243456 | ONVOY Acetabular System | Globus Medical, Inc. | Jun 6, 2025 | SESE |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | Jun 5, 2025 | SESE |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | Apr 23, 2025 | SESE |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | Apr 10, 2025 | SESE |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Feb 6, 2025 | SESE |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | Jan 22, 2025 | SESE |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | Jan 13, 2025 | SESE |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | Nov 8, 2024 | SESE |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | Oct 11, 2024 | SESE |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | Oct 7, 2024 | SESE |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | Oct 7, 2024 | SESE |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | Apr 18, 2024 | SESE |
| K231522 | EMPHASYS Dual Mobility System | Depuy Ireland UC | Feb 15, 2024 | SESE |
Top Applicants
- Zimmer, Inc. — 45 clearances
- Biomet, Inc. — 43 clearances
- Smith & Nephew, Inc. — 32 clearances
- DePuy Orthopaedics, Inc. — 32 clearances
- Depuy, Inc. — 24 clearances
