510(k) · Cleared
ClearedIntellitorq
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gauthier Biomedical, Inc. · HXC Wrench
Cleared on Mar 8, 2018 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 8, 2018
- Review
- 55 days
- Class
- Class I
- Product code
- HXC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HXC devicesHXC Wrench: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HXC
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HXC
Too few HXC 510(k)s in any year since 2007 to give a median.
Recalls per year · HXC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HXC
117in 2025
MAUDE reports naming product code HXC, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 1 | 9 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 1 | 13 |
| 2013 | 0 | — | 0 | 50 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 0 | — | 1 | 100 |
| 2017 | 0 | — | 0 | 118 |
| 2018 | 1 | — | 0 | 111 |
| 2019 | 0 | — | 0 | 154 |
| 2020 | 0 | — | 0 | 142 |
| 2021 | 0 | — | 0 | 160 |
| 2022 | 0 | — | 0 | 143 |
| 2023 | 0 | — | 0 | 145 |
| 2024 | 0 | — | 0 | 125 |
| 2025 | 0 | — | 0 | 117 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is intended to indicate the applied torque according to the set target torque value.
This device is intended for use in surgical procedures on bone and tissue by a surgeon trained in
its intended use.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180092: Intellitorq.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180092
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026