# K180459: VERASENSE for Zimmer Biomet Persona

- Pathway: 510(k) (Traditional)
- Applicant: Orthosensor, Inc.
- Decided: Jun 7, 2018 after 107 days
- Product code: ONN (Intraoperative Orthopedic Joint Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K070108 (2007). 5 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150372: VERASENSE Knee System, Orthosensor, Inc. (2016) Summary page 4.

## Most influential descendants
- K241298: Quadsense (2024), 1 descendant of its own
- K252524: Quadsense (Quadsense and Quadsense Pro) (2025), 0 descendants of its own
- K220830: TrueBalance™ Surgical System (2022), 0 descendants of its own
- K200587: VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder (2020), 0 descendants of its own
- K200665: VERASENSE for Stryker Triathlon (2020), 0 descendants of its own

## Recalls of this device
- Jul 12, 2018 · Class II · Z-0086-2019: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Jul 12, 2018 · Class II · Z-0085-2019: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Jul 12, 2018 · Class II · Z-0087-2019: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Jul 12, 2018 · Class II · Z-0082-2019: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Jul 12, 2018 · Class II · Z-0083-2019: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
- Jul 12, 2018 · Class II · Z-0084-2019: Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

## Indications for use
The VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE is sterile, for single patient use.

Source page: https://510kreport.com/device/K180459
Methodology: https://510kreport.com/methodology