# K183196: Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Feb 14, 2019 after 87 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: 4 generations back to K993239 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012380: Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual Fluoroscopy, Stryker Leibinger (2001) Summary page 6.
- K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap  3D 3.0-Enable, Spinemap  3D 3.0-Sales D, Stryker Corporate (2014) Summary page 6.

## Indications for use
The Fluoroscopy Adapters and Fluoroscopy Trackers are intended to be used as accessories to the Stryker Navigation System. The Fluoroscopy Tracker is connected to the Fluoroscopy Adapter which is attached to the C-arm fluoroscopy system. The Fluoroscopy Tracker transmits signals that are used by the Stryker Navigation System to calculate the spatial relationship between the C-arm and the patient. The Fluoroscopy Adapter and Fluoroscopy Tracker may be used as part of the Stryker Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The Stryker Navigation System, when used with the SpineMap Go software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the pelvis, skull, or spine can be identified. The system assists in the positioning of instruments for procedures on the spine and pelvis, including the following procedures: - Screw Placement in the spine and pelvis - Needle Placement in the spine and pelvis The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker Spine Navigation Systems. It is placed onto the patient’s skin dorsal to the spine. • In combination with intraoperative imaging devices, it enables patient registration for open or percutaneous computer assisted surgery. • When used for patient tracking, the Stryker SpineMask™ Tracker supports minimally invasive procedures on the lumbar and thoracic spine.

Source page: https://510kreport.com/device/K183196
Methodology: https://510kreport.com/methodology