HSB — Rod, Fixation, Intramedullary And Accessories Class II
FDA product code HSB covers "Rod, Fixation, Intramedullary And Accessories", a Class II medical device regulated under 21 CFR 888.3020. 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
- HSB
- Device Class
- Class II
- Regulation Number
- 888.3020
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261481 | stryker | Pangea Femur Reconstruction System | June 29, 2026 |
| K253080 | suzhou and science and technology development | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA0 | June 18, 2026 |
| K261651 | nuvasive specialized orthopedics | Precice Max System and Precice Ankle Salvage System | June 18, 2026 |
| K253155 | beijing fule science and technology development co | Fule Metallic Lockable Intramedullary Nail Systems | June 17, 2026 |
| K253046 | zhejiang decans medical devices co | HERA Interlocking Intramedullary Nailing System | June 16, 2026 |
| K260146 | orthofix | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | May 19, 2026 |
| K253991 | orthofix | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | May 8, 2026 |
| K261043 | globus medical | AUTOBAHN Nailing System | April 24, 2026 |
| K252016 | arthrex | Arthrex Humeral Nails | March 20, 2026 |
| K252961 | fusion orthopedics usa | Fusion FibFix Nail | March 18, 2026 |
| K253566 | zimmer | Affixus Retrograde Femoral Nailing System | March 12, 2026 |
| K253517 | reselute | Reselute Tibial Nail | March 10, 2026 |
| K252196 | arthrex | Arthrex FibuLock Nail System | March 5, 2026 |
| K253591 | paragon 28 | Phantom® Hindfoot TTC/TC Nail System | March 5, 2026 |
| K252025 | satori orthopaedics | Active Intramedullary (AIM) Tibial Nail System | March 4, 2026 |
| K253640 | stryker | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | February 3, 2026 |
| K253749 | zimmer switzerland manufacturing | Affixus® Natural Nail® Proximal Humeral System | December 12, 2025 |
| K252826 | jeil medical corporation | ARIX Femur Nail System | December 10, 2025 |
| K250197 | citieffe | Estremo Fibular Nail | October 17, 2025 |
| K250628 | medshape | DynaNail TTC Fusion System | September 12, 2025 |