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/submissions/OR/subpart-d%E2%80%94prosthetic-devices/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 522) Showing 20 most recent of 522 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252016](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K252016.md) | Arthrex Humeral Nails | Arthrex, Inc. | Mar 20, 2026 | SESE | | [K252961](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K252961.md) | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | Mar 18, 2026 | SESE | | [K253566](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K253566.md) | Affixus Retrograde Femoral Nailing System | Zimmer, Inc. | Mar 12, 2026 | SESE | | [K253517](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K253517.md) | Reselute Tibial Nail | Reselute, Inc. | Mar 10, 2026 | SESE | | [K253591](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K253591.md) | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Mar 5, 2026 | SESE | | [K252196](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K252196.md) | Arthrex FibuLock Nail System | Arthrex, Inc. | Mar 5, 2026 | SESE | | [K252025](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K252025.md) | Active Intramedullary (AIM) Tibial Nail System | Satori Orthopaedics, Inc. | Mar 4, 2026 | SESE | | [K253640](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K253640.md) | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | Feb 3, 2026 | SESE | | [K253749](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K253749.md) | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | Dec 12, 2025 | SESE | | [K252826](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K252826.md) | ARIX Femur Nail System | Jeil Medical Corporation | Dec 10, 2025 | SESE | | [K250197](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250197.md) | Estremo Fibular Nail | Citieffe S.R.L. | Oct 17, 2025 | SESE | | [K250628](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250628.md) | DynaNail TTC Fusion System | MedShape, Inc. | Sep 12, 2025 | SESE | | [K251400](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K251400.md) | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | Aug 20, 2025 | SESE | | [K250163](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250163.md) | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | Aug 13, 2025 | SESE | | [K250622](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250622.md) | Succession™ AFN System | Ortho Solutions UK , Ltd. | Aug 7, 2025 | SESE | | [K251850](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K251850.md) | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | Jul 14, 2025 | SESE | | [K250559](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250559.md) | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | Jun 12, 2025 | SESE | | [K242247](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K242247.md) | ARIX Femur Nail System | Jeil Medical Corporation | Apr 22, 2025 | SESE | | [K250112](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250112.md) | FitboneTM Trochanteric | Orthofix Srl | Apr 10, 2025 | SESE | | [K250623](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K250623.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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