# K130608: Quadcut

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Aug 7, 2013 after 153 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001284 (2000). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000)
- (no number) Quadcut (non-navigated): named in the summary without a submission number

## Most influential descendants
- K133665: Malleable Suction Instruments (2014), 14 descendants of its own
- K141456: The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell (2014), 13 descendants of its own
- K171661: Scopis Extended Instrument Set EM (2017), 3 descendants of its own
- K161697: Acclarent NavWire Sinus Navigation Guidewire (2016), 3 descendants of its own
- K160369: GuideWire (2016), 3 descendants of its own

## Recalls of this device
- Aug 31, 2021 · Class II · Z-0157-2022: There was an increase in complaints related to tip breaks and wobble/vibration.

## Indications for use
The XPS/IPC System is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery. The Medtronic computer-assisted surgery system and its associated applications are intended 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 applications 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/K130608
Methodology: https://510kreport.com/methodology