510(k) · Cleared
ClearedAQrate Robotic Assistance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jan 29, 2019 as substantially equivalent to K171651 (Globus Medical, Inc., 2017) and 1 other predicate after a 187-day review. Its family tree reaches back 19 generations to 2004. 1 of the 430 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 29, 2019
- Review
- 187 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K040583 (2004). 428 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 430 devices in this family, counting this one, has a Class I recall.
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations between
- 3 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 2 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 1 generation backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- This deviceK182000 AQrate Robotic Assistance SystemGlobus Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK240721 ExcelsiusFlex™Globus Medical, Inc. · 2024
Show all 19 generations
- Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 6 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 5 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 4 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 3 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 2 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 1 generation backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- This deviceK182000 AQrate Robotic Assistance SystemGlobus Medical, Inc. · 2019
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K240721ExcelsiusFlex™Globus Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −17 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −16 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −14 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −12 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −11 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −10 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −9 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −8 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −7 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −6 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −5 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −4 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −3 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −2 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −1 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| 0 (this device) | K182000 | AQrate Robotic Assistance System | Globus Medical, Inc. | 2019 | — |
| +1 | K240721 | ExcelsiusFlex™ | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 15 | 0 |
| 1996 | 15 | 0 |
| 1997 | 12 | 0 |
| 1998 | 17 | 0 |
| 1999 | 16 | 0 |
| 2000 | 26 | 0 |
| 2001 | 32 | 0 |
| 2002 | 22 | 0 |
| 2003 | 21 | 0 |
| 2004 | 36 | 0 |
| 2005 | 34 | 0 |
| 2006 | 23 | 0 |
| 2007 | 13 | 0 |
| 2008 | 24 | 0 |
| 2009 | 15 | 0 |
| 2010 | 14 | 1 |
| 2011 | 13 | 0 |
| 2012 | 5 | 0 |
| 2013 | 6 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K171651 | Excelsius GPSSummary page 4…§882.4560 Stereotaxic instrument Product Code(s): OLO Regulatory Class: II Primary Predicate: ExcelsiusGPS™ (K171651) Additional Predicate: Globus Navigation Instruments (K180690) Reference: Medtronic StealthStation (K133444)… | 2017 |
| * | K180690 | Navigation InstrumentsSummary page 4…Product Code(s): OLO Regulatory Class: II Primary Predicate: ExcelsiusGPS™ (K171651) Additional Predicate: Globus Navigation Instruments (K180690) Reference: Medtronic StealthStation (K133444) Purpose: The purpose of this submission is to request clearance of the… | 2018 |
| † | K133444 | Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240721 | ExcelsiusFlex™ | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 59 of the 428 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K240721 (Globus Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 27 other devices also cite its predicate K171651.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instruments and instrument guides are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and…
Read the full statement (115 words)
The AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instruments and instrument guides are designed for use with the Medtronic StealthStation® System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The system is indicated for the placement of spinal screws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182000: AQrate Robotic Assistance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182000
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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