# K183381: Navigation Enabled Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: May 17, 2019 after 162 days
- Product code: OLO (Orthopedic 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
Longest line of descent: 19 generations back to K040583 (2004). 290 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.
- K143628: Navigated Vertex Select Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments, Medtronic Sofamor Danek USA, Inc. (2015) Summary page 4.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.
- K180690: Navigation Instruments, Globus Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K201006: K2M Navigation Instruments (2020), 0 descendants of its own

## Indications for use
Stryker Navigation Enabled Instruments are intended to be used in the preparation and placement of Stryker screws (including XIA 3 (including Serrato), XIA 4.5 (including XIA CT), ES2, Mantis, Mantis Redux, and XIA 2) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are specifically designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Stryker Navigation Enabled Screwdrivers are also compatible with the Medtronic IPC POWEREASE System.

Source page: https://510kreport.com/device/K183381
Methodology: https://510kreport.com/methodology