# K243407: Forcyte Autograft Harvest Kit

- Pathway: 510(k) (Traditional)
- Applicant: Forcyte Medical, LLC
- Decided: Jul 29, 2025 after 270 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- 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 K890925 (1989). 17 ancestors in all.
No later device cites it as a predicate yet.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210631: Avitus (r) Bone Harvester, Avitus Orthopaedics, Inc. (2021) Summary page 5.

## Indications for use
FORCYTE Autograft Harvest Kit is intended to harvest cancellous bone and bone marrow for combination with commercially available allograft or bone void fillers for filling bony voids or gaps that are not intrinsic to the stability of the bony structure.

Source page: https://510kreport.com/device/K243407
Methodology: https://510kreport.com/methodology