# K201900: 3D GraftRasp System

- Pathway: 510(k) (Traditional)
- Applicant: Surgentec
- Decided: Sep 3, 2020 after 57 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: 12 generations back to K013966 (2002). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200431: 3D GraftRasp System, Surgentec (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K201900
Methodology: https://510kreport.com/methodology