LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Class II
FDA product code LPH covers "Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented", a Class II medical device regulated under 21 CFR 888.3358. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261624 | howmedica osteonics corp., dba stryker orthopaedics | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrain | July 10, 2026 |
| K243192 | nextstep arthopedix | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed C | June 5, 2026 |
| K251270 | biomet | Taperloc® Complete Hip Stem | May 19, 2026 |
| 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 |