# K223288: Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jul 21, 2023 after 269 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: 6 generations back to K983831 (1999). 29 ancestors in all.
No later device cites it as a predicate yet.
5 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192703: Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update, Brainlab AG (2020) Summary page 5.
- K162929: Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker, Stryker Corporation (2017) Summary page 5.
- K213989: Cranial EM System, Brainlab AG (2022) Summary page 5.

## Indications for use
Cranial Navigation The Cranial Navigation is intended as image-guided planning and navigation system to enable navigated cranial surgery. It links instruments to a virtual computer image space on patient image data being processed by the navigation platform. The system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, including: • Cranial Resection • Resection of tumors and other lesions • Resection of skull-base tumor or other lesions • AVM Resection • Craniofacial Procedures (including cranial and midfacial bones) • Tumor Resection • Bone Tumor Defect Reconstruction • Bone Trauma Defect Reconstruction • Bone Congenital Defect Reconstructions • Orbital cavity reconstruction procedures • Removal of foreign objects Cranial EM System Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as: • Cranial Resection o Resection of tumors and other lesions o Resection of skull-base tumor or other lesions • Intracranial catheter placement

Source page: https://510kreport.com/device/K223288
Methodology: https://510kreport.com/methodology