# K220830: TrueBalance™ Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: These Three Medical, LLC
- Decided: Sep 15, 2022 after 177 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: 16 generations back to K983831 (1999). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193580: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, Orthosensor, Inc. (2020) Summary page 5.
- K180459: VERASENSE for Zimmer Biomet Persona, Orthosensor, Inc. (2018) Summary page 5.

## Indications for use
TrueBalanceTM Surgical System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool to measure implant alignment and for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. TrueBalance~m Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.

Source page: https://510kreport.com/device/K220830
Methodology: https://510kreport.com/methodology