# K152474: Avitus Bone Harvester

- Pathway: 510(k) (Traditional)
- Applicant: Avitus Orthopaedics, Inc.
- Decided: Oct 23, 2015 after 53 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K890925 (1989). 14 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071732: Marrowminer, Stemcor Systems, Inc. (2007) Summary page 5.

## Most influential descendants
- K170539: Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm (2017), 2 descendants of its own
- K210631: Avitus (r) Bone Harvester (2021), 1 descendant of its own
- K243407: Forcyte Autograft Harvest Kit (2025), 0 descendants of its own

## Recalls of this device
- Feb 18, 2019 · Class II · Z-1046-2019: Breach in the sterile barrier pouch may compromise sterility of the device.

## Indications for use
The AvitusTM Bone Harvester is intended to harvest cancellous bone and bone marrow.

Source page: https://510kreport.com/device/K152474
Methodology: https://510kreport.com/methodology