# K212194: Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System - Pathway: 510(k) (Traditional) - Applicant: Stryker Corporation - Decided: Feb 16, 2023 after 582 days - Product code: HAW (Neurological Stereotaxic Instrument) - Device class: 2 - Regulation: 21 CFR 882.4560 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K050438 (2005). 19 ancestors in all. 1 later device descends from it; 1 cites it directly. 4 of 21 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K212397: StealthStation S8 Cranial v2.0, Medtronic Navigation (2021). Cleared while this submission was under review Summary page 9. - K162309: StealthStation S8 System Platforms and StealthStation Cranial Software, Medtronic Navigation, Inc. (2017) Summary page 9. - K162929: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker, Stryker Corporation (2017) Summary page 9. - K141833: Stylet, 23CM, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-N-GO Pointer, Navigation, Medtronic Navigation, Inc. (2015) Summary page 9. - K143241: MDT Navigable Brain Biopsy Cannula, Izi Medical Products, LLC (2015) Summary page 9. ## Most influential descendants - K233542: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System (2024), 0 descendants of its own ## Recalls of this device - Sep 24, 2026 · Not classified · Z-0314-2027: Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is inside the patient. - Nov 12, 2025 · Class II · Z-0963-2026: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the d ## Indications for use The Stryker Q Guidance System, with the Cranial Guidance Software, 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 assists in the positioning of instruments for cranial procedures, including: - Cranial biopsies - Craniotomies - Craniectomies - Resection of tumors and other lesions - Skull base procedures - Transnasal neurosurgical procedures - Transphenoidal pituitary surgery - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures - General ventricular catheter and shunt placement - Pediatric ventricular catheter and shunt placement The Q Guidance System is intended as an aid for precisely locating anatomical structures in 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 and where reference to a rigid anatomical structure such as the skull, vertebra, or long bone can be identified. The Stryker CranialMask Tracker is intended to be used as an accessory to the CranialMap and the Cranial Guidance software applications. It is intended to be placed on the patient’s facial skin and used in combination with preoperative and intraoperative imaging devices to enable automatic patient registration for open or percutaneous computer-assisted surgery. The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial neurosurgical procedures. The Stryker EM Stylet is indicated for use as an accessory to the Q Guidance System when used with the Cranial Guidance Software and electromagnetic navigation. It is indicated for use in locating anatomical structures during navigated cranial procedures. The system is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The system 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 the skull, can be identified relative to a CT-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. The EM Stylet is indicated for use in the following procedures: * General ventricular catheter and shunt placement * Pediatric ventricular catheter and shunt placement The Stryker Navigated Biopsy Needle is intended to be used as an accessory to the Stryker Q Guidance System when used with the Cranial Guidance Software. It is a side cutting cannula where the cutting action is achieved by rotation of an inner cannula within an outer cannula for use in the stereotaxic biopsy of cranial tissue. The Stryker Navigated Biopsy Needle may be used as part of the Stryker Cranial Guidance 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. Source page: https://510kreport.com/device/K212194 Methodology: https://510kreport.com/methodology