# K131767: Orthosensor Knee Balancer, Verasense Knee System

- Pathway: 510(k) (Special)
- Applicant: Orthosensor, Inc.
- Decided: Nov 8, 2013 after 144 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: 3 generations back to K070108 (2007). 3 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130380: Orthosensor Knee Balancer, Orthosensor, Inc. (2013) Summary page 1.

## Most influential descendants
- K150372: VERASENSE Knee System (2016), 27 descendants of its own
- K163338: OMNIBotics Knee System (2017), 12 descendants of its own
- K200888: OMNIBotics Knee System (2020), 11 descendants of its own
- K221224: Real Intelligence Cori (2022), 9 descendants of its own
- K172462: OrthAlign Plus System (2017), 8 descendants of its own

## Indications for use
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE™ Knee System is sterile, for single patient use.

Source page: https://510kreport.com/device/K131767
Methodology: https://510kreport.com/methodology