510(k) · Cleared
Recalled · Class II · 2021Quadcut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Aug 7, 2013 as substantially equivalent to K001284 (Medtronic Surgical Navigation Technologies, 2000) after a 153-day review. Its family tree reaches back 1 generation to 2000. 17 later devices descend from it. It has been recalled once.
- Decided
- Aug 7, 2013
- Review
- 153 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001284 (2000). 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- This deviceK130608 QuadcutMedtronic Navigation, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK133665 Malleable Suction InstrumentsMedtronic Navigation, Inc. · 2014
- Descendant · 2 generations on · 13 of its ownK141456 The Fiagon Navigation - Extended Instrument Set Ent…Fiagon GmbH · 2014
- Descendant · 3 generations on · 3 of its ownK171661 Scopis Extended Instrument Set EMScopis GmbH · 2017
- Descendant · 3 generations on · 3 of its ownK161697 Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016
- Descendant · 3 generations on · 3 of its ownK160369 GuideWireFiagon GmbH · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K133665Malleable Suction InstrumentsMedtronic Navigation, Inc. · 2014 · cites it directly14descendants
- K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH · 2014 · 2 generations on13descendants
- K171661Scopis Extended Instrument Set EMScopis GmbH · 2017 · 3 generations on3descendants
- K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc. · 2016 · 3 generations on3descendants
- K160369GuideWireFiagon GmbH · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| 0 (this device) | K130608 | Quadcut | Medtronic Navigation, Inc. | 2013 | — |
| +1 | K133665 | Malleable Suction Instruments | Medtronic Navigation, Inc. | 2014 | — |
| +2 | K141456 | The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… | Fiagon GmbH | 2014 | — |
| +3 | K171661 | Scopis Extended Instrument Set EM | Scopis GmbH | 2017 | — |
| +3 | K161697 | Acclarent NavWire Sinus Navigation Guidewire | Acclarent, Inc. | 2016 | — |
| +3 | K160369 | GuideWire | Fiagon GmbH | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | 2000 |
| * | — | Quadcut (non-navigated) Named without a submission number |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2021 | Class II | Z-0157-2022 | Process control | There was an increase in complaints related to tip breaks and wobble/vibration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
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…
Read the full statement (123 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130608: Quadcut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130608
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026