# K150372: VERASENSE Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosensor, Inc.
- Decided: Apr 15, 2016 after 427 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: 4 generations back to K070108 (2007). 4 ancestors in all.
27 later devices descend from it; 3 cite 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)
- K131767: Orthosensor Knee Balancer, Verasense Knee System, Orthosensor, Inc. (2013) Summary page 4.
- K130380: Orthosensor Knee Balancer, Orthosensor, Inc. (2013) Summary page 4.
- K090474: Orthorex Intra-Operative Load Sensor, Orthosensor, Inc. (2009) Summary page 4.

## Most influential descendants
- 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
- K180459: VERASENSE for Zimmer Biomet Persona (2018), 5 descendants of its own

## Indications for use
The VERASENSE Knee System 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 Knee System is sterile, for single patient use.

Source page: https://510kreport.com/device/K150372
Methodology: https://510kreport.com/methodology