# K180949: Steribite

- Pathway: 510(k) (Traditional)
- Applicant: Rjr Surgical, Inc.
- Decided: Nov 8, 2018 after 211 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: 3 generations back to K902819 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150428: Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs, Integra Lifesciences Corp. (2015) Summary page 4.

## Indications for use
The Steribite® Rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.

Source page: https://510kreport.com/device/K180949
Methodology: https://510kreport.com/methodology