# K062711: Ultra Low Profile Rongeur

- Pathway: 510(k) (Traditional)
- Applicant: Baxano, Inc.
- Decided: Mar 7, 2007 after 177 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
No predicates in its family tree.
18 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Codman Laminectomy Shaver: named in the summary without a submission number
- (no number) Integra Ruggles Instrument: named in the summary without a submission number
- (no number) US Surgical Kerrison Spinal Rongeur: named in the summary without a submission number
- (no number) Zeppelin Laminectomy Rongeur: named in the summary without a submission number
- (no number) Bilman Disc FX System: named in the summary without a submission number

## Most influential descendants
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own
- K180876: DTRAX Spinal System (2018), 7 descendants of its own
- K190201: CORUS Spinal System (2019), 6 descendants of its own
- K212636: CORUS Spinal System-X (2021), 5 descendants of its own
- K240625: CORUS Navigation Access System (2024), 4 descendants of its own

## Indications for use
The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

Source page: https://510kreport.com/device/K062711
Methodology: https://510kreport.com/methodology