510(k) · Cleared
ClearedQuadsense (Quadsense and Quadsense Pro)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eventum Orthopaedics, Ltd. · ONN Intraoperative Orthopedic Joint Assessment Aid
Cleared on Sep 9, 2025 as substantially equivalent to K241298 (Eventum Orthopaedics, Ltd., 2024) after a 29-day review. Its family tree reaches back 7 generations to 2007.
- Decided
- Sep 9, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- ONN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K070108 (2007). No later device cites it as a predicate yet.
- Root · 7 generations backK070108 Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
- 6 generations backK090474 Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009
- 5 generations backK130380 Orthosensor Knee BalancerOrthosensor, Inc. · 2013 · Recalled
- 4 generations backK131767 Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013
- 3 generations backK150372 VERASENSE Knee SystemOrthosensor, Inc. · 2016
- 2 generations backK180459 VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 2018 · Recalled
- 1 generation backK241298 QuadsenseEventum Orthopaedics, Ltd. · 2024
- This deviceK252524 Quadsense (Quadsense and Quadsense Pro)Eventum Orthopaedics, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K070108 | Elibra Dynamic Knee Balancer | Synvasive Technology, Inc. | 2007 | — |
| −6 | K090474 | Orthorex Intra-Operative Load Sensor | Orthosensor, Inc. | 2009 | — |
| −5 | K130380 | Orthosensor Knee Balancer | Orthosensor, Inc. | 2013 | 1 |
| −4 | K131767 | Orthosensor Knee Balancer, Verasense Knee System | Orthosensor, Inc. | 2013 | — |
| −3 | K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016 | — |
| −2 | K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018 | 6 |
| −1 | K241298 | Quadsense | Eventum Orthopaedics, Ltd. | 2024 | — |
| 0 (this device) | K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | 2025 | — |
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 ONN? 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 ONN device
- #1 K262253 Lantern Knee Navigation Unit…score 16.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K241298 | QuadsenseSummary page 6…cial 510(k) Premarket Submission Quadsense Common or Usual Name: Intraoperative Orthopaedic Joint Assessment Aid 510(k) Number K241298 Eventum Orthopaedics Ltd Manufacturer Regulation Number: 21 CFR 882… | 2024 |
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.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
How does its category compare?
All ONN devicesONN Intraoperative Orthopedic Joint Assessment Aid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ONN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONN
100in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONN
6in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONN
5in 2025
MAUDE reports naming product code ONN, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 6 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 3 | 100 | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Quadsense and Quadsense Pro Systems are indicated for any medical condition in which primary Total Knee Arthroplasty (TKA) would be indicated, and the patella is resurfaced.
For use as a comparative tool to measure patellofemoral joint force. The Quadsense Sensor and Quadsense Pro Sensor are sterile, for single patient use.
The devices do not make a diagnosis and are not intended to replace a surgeon’s clinical judgement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252524: Quadsense (Quadsense and Quadsense Pro).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252524
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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