# K131214: Cranial Map Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporate
- Decided: Oct 18, 2013 after 172 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
Longest line of descent: 2 generations back to K993239 (2000). 4 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000, Stryker Instruments (2006) Summary page 2.

## Most influential descendants
- K141941: Spinemask Tracker, Spinemap 3D 3.0-Software,Spinemap 3D 3.0-Upgreade, Spinemap  3D 3.0-Enable, Spinemap  3D 3.0-Sales D (2014), 22 descendants of its own
- 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

## Indications for use
The Stryker Navigation System - CranialMap Neuro Module is a navigation surgical software module that, when used with a specific 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 system should be operated only by trained personnel such as surgeons and clinic staff. The CranialMap Neuro Navigation system supports, but is not limited to, the following surgical procedures: * Cranial biopsies * Puncture of abscesses * Cranlotomles * Craniectomnies * Resection of tumors and other lesions * Removal of foreign objects * Skull base procedures * Trananasal neurosurgical procedures * Transphenoidal pituitary surgery * Shunt placement, Including pediatric shunt placement * Placement of electrodes for recording, stimulation and lesion generation * Endoscopic Sinus Surgery (ESS) * Intranasal procedures * Ear Implant procedures * Craniofacial procedures * Skull reconstruction procedures * Orbital cavity reconstruction procedures

Source page: https://510kreport.com/device/K131214
Methodology: https://510kreport.com/methodology