LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II
FDA Device Classification
Classification Details
- Product Code
- LPH
- Device Class
- Class II
- Regulation Number
- 888.3358
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252623 | zimmer | G7® Revision Acetabular System | February 4, 2026 |
| K251043 | medacta international | Mpact 3D Metal Implants Extension DMLS Technology | January 28, 2026 |
| K252067 | restor3d | Velora Acetabular System | December 5, 2025 |
| K252846 | shalby advanced technologies, inc. dba consensus orthopedics | TaperSet Hip System | November 20, 2025 |
| K251833 | encore medical, l.p | EMPOWR Acetabular® Liner Extension | November 12, 2025 |
| K251718 | lima corporate | ArTT Augments and Buttresses and Bone Screws | August 29, 2025 |
| K250989 | howmedica osteonics corp (dba stryker orthopaedics) | Stryker and Serf hip devices | July 25, 2025 |
| K243456 | globus medical | ONVOY Acetabular System | June 6, 2025 |
| K242744 | corin u.s.a. limited | Trinity EVO Acetabular Shell | June 5, 2025 |
| K242232 | medacta international | Mpact 3D Metal Augments II | April 23, 2025 |
| K242045 | kyocera medical technologies | Initia T3 Acetabular Hemispherical Shell System | April 10, 2025 |
| K243784 | howmedica osteonics corp., dba stryker orthopaedics | Stryker Orthopaedics Hip Devices Labeling Update | February 6, 2025 |
| K243977 | depuy ireland uc | EMPHASYS Acetabular System | January 22, 2025 |
| K241059 | adler ortho | Pantheon Proximal Femur Reconstruction (PFR) System | January 13, 2025 |
| K241636 | waldemar link gmbh and co. kg | MobileLink Acetabular Cup System - Line Extension (Multiple) | November 8, 2024 |
| K242833 | ortho development | Legend® Acetabular Shell | October 11, 2024 |
| K242084 | depuy ireland uc | EMPHASYS Acetabular Shell with RapiTite HA | October 7, 2024 |
| K242375 | smith and nephew | OR3O Dual Mobility System | October 7, 2024 |
| K240046 | microport orthopedics | Ethylene Oxide Sterilization Supplier Change for MPO Hips | April 18, 2024 |
| K231522 | depuy ireland uc | EMPHASYS Dual Mobility System | February 15, 2024 |