# K061108: Stryker Auto Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: Feb 2, 2007 after 288 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K852143 (1985). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030576: Anspach Irrigation Pump and Irrigation Pump II, The Anspach Effort, Inc. (2003) Summary page 1.

## Indications for use
The Stryker Auto Irrigation System is intended for use with the Maestro Pneumatic System for providing controlled, cooling irrigation during cutting, shaping, and removal of bone. Contraindications * The Stryker Auto Irrigation System is contraindicated for use with any fluids other than those specifically for surgical irrigation.

Source page: https://510kreport.com/device/K061108
Methodology: https://510kreport.com/methodology