AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k) clearance K253080 · decided 2026-06-18
Clearance details
- K-number
- K253080
- Device name
- AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- Applicant
- Suzhou and Science & Technology Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-23
- Decision date
- 2026-06-18
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Zhangjiagang, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Pangea Femur Reconstruction System (K261481) | Stryker GmbH | 2026-06-29 |
| Precice™ Max System and Precice™ Ankle Salvage System (K261651) | NuVasive Specialized Orthopedics | 2026-06-18 |
| Fule Metallic Lockable Intramedullary Nail Systems (K253155) | Beijing Fule Science & Technology Development Co., Ltd. | 2026-06-17 |
| HERA Interlocking Intramedullary Nailing System (K253046) | ZheJiang Decans Medical Devices Co., Ltd. | 2026-06-16 |
| FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146) | Orthofix Srl | 2026-05-19 |
| Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991) | Orthofix Srl | 2026-05-08 |
| AUTOBAHN™ Nailing System (K261043) | Globus Medical, Inc. | 2026-04-24 |
| Arthrex Humeral Nails (K252016) | Arthrex, Inc. | 2026-03-20 |
| Fusion FibFix Nail (K252961) | Fusion Orthopedics USA, LLC | 2026-03-18 |
| Affixus Retrograde Femoral Nailing System (K253566) | Zimmer, Inc. | 2026-03-12 |
| Reselute Tibial Nail (K253517) | Reselute, Inc. | 2026-03-10 |
| Phantom® Hindfoot TTC/TC Nail System (K253591) | Paragon 28, Inc. | 2026-03-05 |
Recalls involving this device
No recalls on record reference this clearance.