# K252524: Quadsense (Quadsense and Quadsense Pro)

- Pathway: 510(k) (Special)
- Applicant: Eventum Orthopaedics, Ltd.
- Decided: Sep 9, 2025 after 29 days
- Product code: ONN (Intraoperative Orthopedic Joint Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K070108 (2007). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241298: Quadsense, Eventum Orthopaedics, Ltd. (2024) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K252524
Methodology: https://510kreport.com/methodology