# K141910: Intraosseous Cannula System Bio-MAC¿ and Bio-CORE

- Pathway: 510(k) (Traditional)
- Applicant: Biologic Therapies, Inc.
- Decided: May 4, 2015 after 293 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: 5 generations back to K890925 (1989). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072045: Oncontrol Bone Marrow Biopsy System, Vidacare Corporation (2007) Summary page 4.

## Recalls of this device
- Jan 23, 2015 · Class II · Z-1374-2015: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
- Jan 23, 2015 · Class II · Z-1373-2015: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution

## Indications for use
The Bio-MAC™ Bone Marrow Aspiration Cannula System is for use in the intraosscous aspiration of viscous bone marrow material in the human body. The Bio-CORE™ Bone Marrow Biopsy Cannula System is for use in the intraosscous harvest and biopsy of “solid core™ bone marrow material in the human body.

Source page: https://510kreport.com/device/K141910
Methodology: https://510kreport.com/methodology