# K152872: K2M Fenestrated Tap System

- Pathway: 510(k) (Traditional)
- Applicant: K2m
- Decided: Jan 5, 2016 after 97 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: 1 generation back to K052638 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052638: Abbott Spine, Inc. Spinnaker System, Abbott Spine, Inc. (2005) Summary page 4.

## Recalls of this device
- Apr 18, 2019 · Class II · Z-1491-2019: The products are mislabeled.
- Apr 18, 2019 · Class II · Z-1492-2019: The products are mislabeled.

## Indications for use
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site. When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

Source page: https://510kreport.com/device/K152872
Methodology: https://510kreport.com/methodology