# K253080: AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou and Science & Technology Development Corp.
- Decided: Jun 18, 2026 after 268 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951740 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172830: Double Medical Femoral Nail System, Double Medical Technology, Inc. (2018) Summary page 5.

## Indications for use
AND Medical Femoral Nail System is Suitable for intramedullary fixation of femoral fractures. Indications for use of the PFNAO2(Length 170 mm - 240 mm) include: — Pertrochanteric fractures; — Intertrochanteric fractures; — High subtrochanteric fractures. Indications for use of the PFNAO1 (Length 320 mm - 420 mm), include: — Low and extended subtrochanteric fractures; — |Ipsilateral trochanteric fractures; — Combination fractures (in the proximal femur); — Pathological fractures.

Source page: https://510kreport.com/device/K253080
Methodology: https://510kreport.com/methodology