# K262235: ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated EM Tracking (187BL4040EM);ApexCut ™ Blade with Automated EM Tracking (187BL4060EM);ApexCut ™ Blade with Automated EM Tracking (187BL2975EM);ApexCut ™ Blade with Automated EM Tracking (187BL3590EM);ApexCut ™ Blade with Automated EM Tracking (187BL4000LEM)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Sep 4, 2026 after 65 days
- Product code: PGW (Ear, Nose, And Throat 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 K001284 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130608: Quadcut, Medtronic Navigation, Inc. (2013) Summary page 5.

## Indications for use
The ApexCut ™ EM navigated blades are surgical instruments used in conjunction with IPC/XPS and Medtronic computer-assisted surgery systems which are intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology (ENT) and head and neck surgery and as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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- or MR-based model, or digitized landmarks of the anatomy. The system and its associated accessories should be used only as an adjunct for surgical guidance. They do not replace the surgeon’s knowledge, expertise, or judgment.

Source page: https://510kreport.com/device/K262235
Methodology: https://510kreport.com/methodology