Estremo Fibular Nail
FDA 510(k) K250197 · Citieffe S.R.L.
510(k) numberK250197
Submission
- Device name
- Estremo Fibular Nail
- Applicant
- Citieffe S.R.L.
Calderara Di Reno, IT - Received
- January 23, 2025
- Decision date
- October 17, 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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|---|---|---|---|
| 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 |
|---|---|---|
| K183666 | EBA One Nailing SystemHSB · Traditional | 11/14/2019SE |
| K181540 | Estremo Citieffe Nailing SystemHSB · Traditional | 01/16/2019SE |
| K180150 | PL8 Wrist Reconstruction PlateHRS · Traditional | 08/02/2018SE |
| K163323 | Dolphix® External Fixation System MR ConditionalKTT · Traditional | 03/20/2017SE |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With HydroxyapatiteJDW · Traditional | 07/07/2015SE |
| K132363 | Dolphix External Fixation SystemKTT · Traditional | 01/16/2014SE |
| K131005 | EBA2 Femoral Nailing SystemHSB · Special | 06/25/2013SE |
Questions and answers
When was Estremo Fibular Nail cleared by the FDA?
Estremo Fibular Nail (K250197) received a 510(k) decision of Substantially Equivalent on October 17, 2025, 267 days after the submission was received.
What is the product code of K250197?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.