# K150468: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

- Pathway: 510(k) (Traditional)
- Applicant: K2 Medical GmbH & Co. KG
- Decided: Feb 29, 2016 after 371 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 K943635 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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.
- K081651: Instrumed Rongeur, Instrumed International, Inc. (2008) Summary page 4.

## Most influential descendants
- K210741: KLS Martin Neuro Rongeurs (2022), 0 descendants of its own

## Indications for use
Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.

Source page: https://510kreport.com/device/K150468
Methodology: https://510kreport.com/methodology