# K070179: Trokabone, Trokabone Sternal

- Pathway: 510(k) (Traditional)
- Applicant: PAJUNK GmbH Medizintechnologie
- Decided: Mar 7, 2007 after 47 days
- Product code: FCG (Biopsy Needle)
- 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 K871390 (1987). 21 ancestors in all.
No later device cites it as a predicate yet.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013692: Trapsystem Set, H.S. Hospital Service S.R.L. (2002) Summary page 1.
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy, Sterylab S.R.L. (2005) Summary page 2.

## Indications for use
Pajunk's TrokaBone puncture set consists of a modular system for the extraction of bone and bone marrow samples for histological examinations. The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.

Source page: https://510kreport.com/device/K070179
Methodology: https://510kreport.com/methodology