# K152734: Kerrison Rongeurs

- Pathway: 510(k) (Traditional)
- Applicant: Vitalitec Medizintechnik GmbH
- Decided: Jun 18, 2016 after 270 days
- Product code: HAE (Rongeur, Manual)
- Device class: 2
- Regulation: 21 CFR 882.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902819 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092227: Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs, Integra Lifesciences Corp. (2010) Summary page 4.

## Indications for use
Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.

Source page: https://510kreport.com/device/K152734
Methodology: https://510kreport.com/methodology