ARIX Femur Nail System
FDA 510(k) K252826 · Jeil Medical Corporation
510(k) numberK252826
Submission
- Device name
- ARIX Femur Nail System
- Applicant
- Jeil Medical Corporation
Seoul, KR - Received
- September 5, 2025
- Decision date
- December 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252246 | Leforte MMF SystemJEY · Traditional | 04/02/2026SE |
| K251431 | FIX-C PEEK ACIF SA SystemOVE · Traditional | 06/27/2025SE |
| K243973 | FIX-L PEEK PLIF and T-PLIF SystemMAX · Traditional | 06/12/2025SE |
| K242751 | ARIX Pectus Bar SystemHRS · Traditional | 05/30/2025SE |
| K242247 | ARIX Femur Nail SystemHSB · Traditional | 04/22/2025SE |
| K243915 | FIX-C 3D Ti ACIF SystemODP · Traditional | 02/18/2025SE |
| K243004 | Xpine Spinal Fixation SystemNKB · Traditional | 11/08/2024SE |
| K231251 | FlexWing Anterior Cervical Plate SystemKWQ · Traditional | 07/24/2024SE |
| K233912 | ARIX Cannulated Screw SystemHWC · Traditional | 03/11/2024SE |
| K231887 | ARIX Ankle Distal Tibia SystemHRS · Traditional | 12/14/2023SE |
Questions and answers
When was ARIX Femur Nail System cleared by the FDA?
ARIX Femur Nail System (K252826) received a 510(k) decision of Substantially Equivalent on December 10, 2025, 96 days after the submission was received.
What is the product code of K252826?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.