# K210631: Avitus (r) Bone Harvester

- Pathway: 510(k) (Special)
- Applicant: Avitus Orthopaedics, Inc.
- Decided: Mar 31, 2021 after 28 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: 7 generations back to K890925 (1989). 16 ancestors in all.
1 later device descends 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)
- 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, Avitus Orthopaedics, Inc. (2017) Summary page 5.

## Most influential descendants
- K243407: Forcyte Autograft Harvest Kit (2025), 0 descendants of its own

## Indications for use
The Avitus® Bone Harvester is intended to harvest cancellous bone and marrow; to debride and capture infected, necrotic or diseased cancellous bone (e.g. osteomyelitis, cancellous bone tumors).

Source page: https://510kreport.com/device/K210631
Methodology: https://510kreport.com/methodology