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 530)
Showing 20 most recent of 530 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | Jun 29, 2026 | SESE |
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | Jun 18, 2026 | SESE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | Jun 18, 2026 | SESE |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | Jun 17, 2026 | SESE |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | Jun 16, 2026 | SESE |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | May 19, 2026 | SESE |
| K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | May 8, 2026 | SESE |
| K261043 | AUTOBAHN™ Nailing System | Globus Medical, Inc. | Apr 24, 2026 | SESE |
| 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 |
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
