# K241298: Quadsense

- Pathway: 510(k) (Traditional)
- Applicant: Eventum Orthopaedics, Ltd.
- Decided: Oct 4, 2024 after 149 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: 6 generations back to K070108 (2007). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180459: VERASENSE for Zimmer Biomet Persona, Orthosensor, Inc. (2018) Summary page 5.

## Most influential descendants
- K252524: Quadsense (Quadsense and Quadsense Pro) (2025), 0 descendants of its own

## Indications for use
The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced. For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use. The device does not make a diagnosis and is not intended to replace a surgeon’s clinical judgement.

Source page: https://510kreport.com/device/K241298
Methodology: https://510kreport.com/methodology