# K230015: OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

- Pathway: 510(k) (Traditional)
- Applicant: Laurane Medical Sas
- Decided: Jun 16, 2023 after 164 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). 35 ancestors in all.
No later device cites it as a predicate yet.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113872: The Oncontrol Bone Access and Bone Biopsy System by Vidacare, Vidacare Corporation (2012) Summary page 5.
- K142377: The OnControl Bone Marrow Biopsy System by Vidacare, Vidacare, LLC (2014) Summary page 5.

## Indications for use
The Omnibone™ Bone Marrow Biopsy Kit is indicated for bone marrow aspiration and biopsy of the anterior or the posterior iliac crest of adult patients. The Omnibone™ Bone Biopsy Kit is indicated for bone biopsy of the vertebral body and bone lesions.

Source page: https://510kreport.com/device/K230015
Methodology: https://510kreport.com/methodology