# K251648: GPS Advanced; GPS Advanced Cannula

- Pathway: 510(k) (Special)
- Applicant: Prosidyan, Inc.
- Decided: Jun 24, 2025 after 26 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K013966 (2002). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241426: GPS Advanced; 5 cc GPS Advanced Cannula, Prosidyan, Inc. (2024) Summary page 5.

## Indications for use
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.

Source page: https://510kreport.com/device/K251648
Methodology: https://510kreport.com/methodology