# K112468: The Oncontrol Bone Access System by Vidacare

- Pathway: 510(k) (Traditional)
- Applicant: Regulatory Specialists, Inc.
- Decided: Oct 20, 2011 after 55 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: 6 generations back to K890925 (1989). 18 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081713: Vertebral Access System by Vidacare, Vidacare Corporation (2008) Summary page 1.
- K022169: Clearview Plus Bone and Vertebral Body Biopsy Needles, Parallax Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K113872: The Oncontrol Bone Access and Bone Biopsy System by Vidacare (2012), 2 descendants of its own
- K230015: OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (2023), 0 descendants of its own
- K213896: BD Trek Powered Bone Biopsy System (2022), 0 descendants of its own

## Indications for use
The OnControl Bone Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and for bone biopsy. This system does not contain cement.

Source page: https://510kreport.com/device/K112468
Methodology: https://510kreport.com/methodology