# K081651: Instrumed Rongeur

- Pathway: 510(k) (Traditional)
- Applicant: Instrumed International, Inc.
- Decided: Aug 8, 2008 after 57 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: 1 generation back to K943635 (1994). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062711: Ultra Low Profile Rongeur, Baxano, Inc. (2007) Summary page 1.
- K023868: Dan Kerrison Rongeurs, Models K1 + Billy 1, Dannoritzer Medical Instruments (2003) Summary page 1.
- K943635: Ultra-Line Rongeur, V. Mueller Neuro/Spine (1994) Summary page 1.
- (no number) K-MEDIC/TELEFLEX; IVD Rongeurs and Spinal Punches: named in the summary without a submission number

## Most influential descendants
- K150468: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs (2016), 1 descendant of its own
- K210741: KLS Martin Neuro Rongeurs (2022), 0 descendants of its own
- K131851: Osteomed Neuro Rongeur (2013), 0 descendants of its own

## Indications for use
The intended use of Instrumed Rongeur is to access, cut and bite soft tissue and bone during surgery involving the spinal column.

Source page: https://510kreport.com/device/K081651
Methodology: https://510kreport.com/methodology