# K141673: Ivas 8 Gauge Bone Biopsy Kit

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Sep 4, 2014 after 73 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: 3 generations back to K890925 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits, Stryker Corp. (2003) Summary page 4.

## Indications for use
The Stryker iVAS Bone Biopsy Kit can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.

Source page: https://510kreport.com/device/K141673
Methodology: https://510kreport.com/methodology