# K003111: Stryker Navigation System-Spine & Fluoroscopy Modules

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: Jan 4, 2001 after 92 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122211: Synthes Navigable Pedicle Preparation Instruments (2012), 20 descendants of its own
- K191943: SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (2019), 8 descendants of its own
- K201661: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (2020), 7 descendants of its own
- K170937: VIPER PRIME navigated inserter (2017), 6 descendants of its own
- K212756: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set (2022), 5 descendants of its own

Source page: https://510kreport.com/device/K003111
Methodology: https://510kreport.com/methodology