# K062849: Smith & Nephew Duonics Power II Shaver System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 19, 2007 after 116 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K232290: INTELLIO SHIFT System (2023), 0 descendants of its own
- K172092: Reprocessed Shavers/Burs (2017), 0 descendants of its own

## Indications for use
The Smith & Nephew DYONICS Power II Shaver System control unit is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

Source page: https://510kreport.com/device/K062849
Methodology: https://510kreport.com/methodology