HSB · Rod, Fixation, Intramedullary And Accessories
Orthopedic · 21 CFR 888.3020 · Class 2
Overview
| Product Code | HSB |
|---|---|
| Device Name | Rod, Fixation, Intramedullary And Accessories |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 522)
Showing 20 most recent of 522 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | Mar 20, 2026 | SESE |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | Mar 18, 2026 | SESE |
| K253566 | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | Mar 12, 2026 | SESE |
| K253517 | Reselute Tibial Nail | Reselute, Inc. | Mar 10, 2026 | SESE |
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Mar 5, 2026 | SESE |
| K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | Mar 5, 2026 | SESE |
| K252025 | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | Mar 4, 2026 | SESE |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | Feb 3, 2026 | SESE |
| K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | Dec 12, 2025 | SESE |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | Dec 10, 2025 | SESE |
| K250197 | Estremo Fibular Nail | Citieffe S.R.L. | Oct 17, 2025 | SESE |
| K250628 | DynaNail TTC Fusion System | MedShape, Inc. | Sep 12, 2025 | SESE |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | Aug 20, 2025 | SESE |
| K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | Aug 13, 2025 | SESE |
| K250622 | Succession AFN System | Ortho Solutions UK , Ltd. | Aug 7, 2025 | SESE |
| K251850 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Jul 14, 2025 | SESE |
| K250559 | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | Jun 12, 2025 | SESE |
| K242247 | ARIX Femur Nail System | Jeil Medical Corporation | Apr 22, 2025 | SESE |
| K250112 | FitboneTM Trochanteric | Orthofix Srl | Apr 10, 2025 | SESE |
| K250623 | Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | Apr 1, 2025 | SESE |
Top Applicants
- Howmedica Osteonics Corp. — 38 clearances
- Howmedica Corp. — 23 clearances
- Synthes (Usa) — 22 clearances
- Zimmer, Inc. — 17 clearances
- Nuvasive Specialized Orthopedics, Inc. — 16 clearances
