# K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap  3D 3.0-Enable, Spinemap  3D 3.0-Sales D

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporate
- Decided: Oct 31, 2014 after 106 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: 3 generations back to K993239 (2000). 7 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 30 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.
- K131214: Cranial Map Neuro, Stryker Corporate (2013) Summary page 6.
- K022579: Stryker Navigation System-Knee Module, Stryker Leibinger (2003) Summary page 6.

## Most influential descendants
- K172034: Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap (2017), 12 descendants of its own
- K220593: Spine Guidance Software, Stryker Q Guidance System (2022), 10 descendants of its own
- K203205: Navigated Spine Instruments (2021), 8 descendants of its own
- K240662: Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (2024), 7 descendants of its own
- K221028: SURGIVISIO Device (2022), 7 descendants of its own

## Indications for use
The Stryker SpineMap® 3D Navigation System, when used with a Stryker computer workstation, 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 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 SpineMap® 3D Navigation System assists in precise positioning of instruments for procedures on the spine, including: • Pedicle screw placement The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker SpineMap® 3D Navigation System. It is placed onto the patient’s skin dorsal to the spine. • In combination with intraoperative imaging devices, it enables automatic 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/K141941
Methodology: https://510kreport.com/methodology