Arthrex Humeral Nails
FDA 510(k) K252016 · Arthrex, Inc.
510(k) numberK252016
Submission
- Device name
- Arthrex Humeral Nails
- Applicant
- Arthrex, Inc.
Naples, FL, US - Received
- June 27, 2025
- Decision date
- March 20, 2026
- 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 |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | Zimmer, Inc. | 03/12/2026SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262451 | Arthrex DynaNite StaplesJDR · Traditional | 09/01/2026SE |
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | 08/07/2026SE |
| K260624 | Arthrex Radial Head Replacement SystemKWI · Traditional | 07/30/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | 06/26/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | 06/25/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | 05/28/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | 05/08/2026SE |
| K260561 | Arthrex FiberTak Suture AnchorMBI · Special | 03/20/2026SE |
| K260405 | FiberTape ButtonMBI · Special | 03/09/2026SE |
| K252196 | Arthrex FibuLock Nail SystemHSB · Traditional | 03/05/2026SE |
Questions and answers
When was Arthrex Humeral Nails cleared by the FDA?
Arthrex Humeral Nails (K252016) received a 510(k) decision of Substantially Equivalent on March 20, 2026, 266 days after the submission was received.
What is the product code of K252016?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.