# K062640: Stryker Navigation System - Cranial Module, Model 6000-650-000 - Pathway: 510(k) (Traditional) - Applicant: Stryker Instruments - Decided: Dec 14, 2006 after 99 days - Product code: HAW (Neurological Stereotaxic Instrument) - Device class: 2 - Regulation: 21 CFR 882.4560 - Recalls of this device: 19 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K993239 (2000). 3 ancestors in all. 50 later devices descend from it; 5 cite it directly. 1 of 54 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K993239: Stryker Navigation System - Neuro Module, Model 6000-XXX-XXX, Stryker Corp. (2000) Summary page 1. - K002732: Stryker Navigation System - Ent Module, Stryker Corp. (2000) Summary page 1. - K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 1. ## Most influential descendants - K131214: Cranial Map Neuro (2013), 26 descendants of its own - 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 - K141551: Profess Software, Profess Curved 70 (Degrees) Suction, Profess Curved 70 (Degrees) Suction, Profess Curved 90 (Degrees) (2014), 20 descendants of its own - K153240: Styrker OrthoMap Express Knee System (2016), 17 descendants of its own - K162341: Stryker OrthoMap Precision Knee system (2016), 16 descendants of its own ## Recalls of this device - Nov 10, 2010 · Not classified · Z-1419-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1410-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1418-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1405-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1404-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1407-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1417-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1409-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1408-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1406-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1412-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1411-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1415-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1414-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1416-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1413-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1402-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1403-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead - Nov 10, 2010 · Not classified · Z-1420-2011: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead ## Indications for use The system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures: ENT Procedures * Endoscopic Sinus Surgery (ESS) * Intranasal procedures * Ear implant procedures Neuro Procedures * Cranial biopsies * Puncture of abscesses * Craniotomies * Craniectomies * Resection of tumors and other lesions * Removal of foreign objects * Skull base procedures * Transnasal neurosurgical procedures * Transphenoidal pituitary surgery * Shunt placement, including pediatric shunt placement * Placement of electrodes for recording, stimulation and lesion generation * Craniofacial procedures * Skull reconstruction procedures * Orbital cavity reconstruction procedures Contraindications * Surgical situation where increasing surgical time may be detrimental to the patient. Source page: https://510kreport.com/device/K062640 Methodology: https://510kreport.com/methodology