Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3020](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3020) → HSB — Rod, Fixation, Intramedullary And Accessories

# HSB · Rod, Fixation, Intramedullary And Accessories

_Orthopedic · 21 CFR 888.3020 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/HSB

## Overview

- **Product Code:** HSB
- **Device Name:** Rod, Fixation, Intramedullary And Accessories
- **Regulation:** [21 CFR 888.3020](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3020)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **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 525)

Showing 20 most recent of 525 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260146](/device/K260146.md) | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | May 19, 2026 | SESE |
| [K253991](/device/K253991.md) | Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA | Orthofix Srl | May 8, 2026 | SESE |
| [K261043](/device/K261043.md) | AUTOBAHN™ Nailing System | Globus Medical, Inc. | Apr 24, 2026 | SESE |
| [K252016](/device/K252016.md) | Arthrex Humeral Nails | Arthrex, Inc. | Mar 20, 2026 | SESE |
| [K252961](/device/K252961.md) | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | Mar 18, 2026 | SESE |
| [K253566](/device/K253566.md) | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | Mar 12, 2026 | SESE |
| [K253517](/device/K253517.md) | Reselute Tibial Nail | Reselute, Inc. | Mar 10, 2026 | SESE |
| [K253591](/device/K253591.md) | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Mar 5, 2026 | SESE |
| [K252196](/device/K252196.md) | Arthrex FibuLock Nail System | Arthrex, Inc. | Mar 5, 2026 | SESE |
| [K252025](/device/K252025.md) | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | Mar 4, 2026 | SESE |
| [K253640](/device/K253640.md) | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | Feb 3, 2026 | SESE |
| [K253749](/device/K253749.md) | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | Dec 12, 2025 | SESE |
| [K252826](/device/K252826.md) | ARIX Femur Nail System | Jeil Medical Corporation | Dec 10, 2025 | SESE |
| [K250197](/device/K250197.md) | Estremo Fibular Nail | Citieffe S.R.L. | Oct 17, 2025 | SESE |
| [K250628](/device/K250628.md) | DynaNail TTC Fusion System | MedShape, Inc. | Sep 12, 2025 | SESE |
| [K251400](/device/K251400.md) | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | Aug 20, 2025 | SESE |
| [K250163](/device/K250163.md) | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | Aug 13, 2025 | SESE |
| [K250622](/device/K250622.md) | Succession™ AFN System | Ortho Solutions UK , Ltd. | Aug 7, 2025 | SESE |
| [K251850](/device/K251850.md) | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Jul 14, 2025 | SESE |
| [K250559](/device/K250559.md) | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | Jun 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

---

**Source:** [https://fda.innolitics.com/productcode/HSB](https://fda.innolitics.com/productcode/HSB)

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