# K200431: 3D GraftRasp System

- Pathway: 510(k) (Traditional)
- Applicant: Surgentec
- Decided: May 18, 2020 after 87 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: 11 generations back to K013966 (2002). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170675: Graftgun Universal Graft Delivery System, SurGenTec, LLC (2017) Summary page 4.
- (no number) Bone Rasp No64 7 inches 3mm/4mm: named in the summary without a submission number

## Most influential descendants
- K201900: 3D GraftRasp System (2020), 0 descendants of its own

## Indications for use
The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone and for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Source page: https://510kreport.com/device/K200431
Methodology: https://510kreport.com/methodology