# K113872: The Oncontrol Bone Access and Bone Biopsy System by Vidacare

- Pathway: 510(k) (Traditional)
- Applicant: Vidacare Corporation
- Decided: Mar 8, 2012 after 69 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890925 (1989). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112468: The Oncontrol Bone Access System by Vidacare, Regulatory Specialists, Inc. (2011) Summary page 1.
- K022169: Clearview Plus Bone and Vertebral Body Biopsy Needles, Parallax Medical, Inc. (2002) Summary page 1.
- K962425: Bonopty Coaxial Bone Biopsy System with Eccentric Drill (10-1072,3,4), Radi Medical Systems AB (1996) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Mar 8, 2021 · Class II · Z-1374-2021: Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biop
- Nov 8, 2016 · Class II · Z-0677-2017: Sterility: Due to a potential incomplete seal on the outer sterile package.

## Indications for use
The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

Source page: https://510kreport.com/device/K113872
Methodology: https://510kreport.com/methodology