# K130380: Orthosensor Knee Balancer

- Pathway: 510(k) (Special)
- Applicant: Orthosensor, Inc.
- Decided: Jun 13, 2013 after 119 days
- Product code: ONN (Intraoperative Orthopedic Joint Assessment Aid)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K070108 (2007). 2 ancestors in all.
29 later devices descend from it; 2 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)
- K090474: Orthorex Intra-Operative Load Sensor, Orthosensor, Inc. (2009) Summary page 1.

## Most influential descendants
- K131767: Orthosensor Knee Balancer, Verasense Knee System (2013), 28 descendants of its own
- 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

## Recalls of this device
- Dec 5, 2014 · Class II · Z-1029-2015: Presence of one inoperable (dead) sensor pad.

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

Source page: https://510kreport.com/device/K130380
Methodology: https://510kreport.com/methodology