# K233368: Allograft Delivery Device (OFAC-C)

- Pathway: 510(k) (Traditional)
- Applicant: Bioventus, LLC
- Decided: Jun 25, 2024 after 267 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: 8 generations back to K013966 (2002). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142661: Bi-Portal Bone Graft Delivery Device, Spinal Surgical Strategies, LLC (2014) Summary page 4.

## Indications for use
The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.

Source page: https://510kreport.com/device/K233368
Methodology: https://510kreport.com/methodology