AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k) K253080 · Suzhou and Science & Technology Development Corp.
510(k) numberK253080
Submission
- Device name
- AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- Applicant
- Suzhou and Science & Technology Development Corp.
Zhangjiagang, CN - Received
- September 23, 2025
- Decision date
- June 18, 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
Other 510(k)s with product code HSB
| 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 |
| 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 |
| K253566 | Affixus Retrograde Femoral Nailing SystemHSB · Traditional | Zimmer, Inc. | 03/12/2026SE |
Questions and answers
When was AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) cleared by the FDA?
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 268 days after the submission was received.
What is the product code of K253080?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.