# K162929: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corporation
- Decided: Feb 22, 2017 after 126 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: 3 generations back to K993239 (2000). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131214: Cranial Map Neuro, Stryker Corporate (2013) Summary page 8.

## Most influential descendants
- 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 (2023), 1 descendant of its own
- 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
- K223288: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI (2023), 0 descendants of its own

## Indications for use
The Stryker Navigation System, with the CranialMap 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 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 system assists in the positioning of instruments for cranial procedures, including: - 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 - Endoscopic Sinus Surgery (ESS) - Intranasal procedures - Ear implant procedures - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures The user should consult Chapter "System Accuracy" of the safety information to assess if the accuracy of the system is suitable for their needs. The Stryker CranialMap Planning software application, when used on a compliant computer, is intended as a planning software to enable open or percutaneous computer-assisted surgery. The software application is indicated for any medical condition in which the use of computer-assisted planning may be appropriate. The software application should be operated only by trained personnel such as surgeons and clinic staff. This can include the following cranial 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 - Endoscopic Sinus Surgery (ESS) - Intranasal procedures - Ear implant procedures - Craniofacial procedures - Skull reconstruction procedures - Orbital cavity reconstruction procedures The Stryker CranialMask Tracker is intended to be used as an accessory to the Stryker Navigation System, with the CranialMap software application. It is placed onto the patient’s face on top of the skin. - In combination with preoperative and intraoperative imaging devices, it enables 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 procedures.

Source page: https://510kreport.com/device/K162929
Methodology: https://510kreport.com/methodology