AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)— 510(k) K253080

Name: FDA 510(k) clearance K253080
Creator: U.S. Food and Drug Administration
Published: 2026-06-18

Substantially Equivalent

Suzhou and Science & Technology Development Corp.

FDA 510(k) clearance K253080 for AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02), Substantially Equivalent on 2026-06-18. Applicant: Suzhou and Science & Technology Development Corp.. Device class: 2.

Clearance details

Applicant: Suzhou and Science & Technology Development Corp.
Product code: Code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2025-09-23
Decision date: 2026-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhangjiagang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSB

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K261481 — Pangea Femur Reconstruction System2026-06-29
K261651 — Precice Max System and Precice Ankle Salvage System2026-06-18
K253155 — Fule Metallic Lockable Intramedullary Nail Systems2026-06-17
K253046 — HERA Interlocking Intramedullary Nailing System2026-06-16
K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM2026-05-19

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.