TrueBalance™ Surgical System

FDA 510(k) K220830 · These Three Medical, LLC

Substantially Equivalent

510(k) numberK220830

Submission

Device name
TrueBalance™ Surgical System
Applicant
These Three Medical, LLC
Phoenix, AZ, US
Received
March 22, 2022
Decision date
September 15, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ONN – Intraoperative Orthopedic Joint Assessment Aid
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Specialty
Neurology

Measurement and interpretation of orthopedic joint information.

Other 510(k)s with product code ONN

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K253507Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, KneeONN · Traditional Orthalign, Inc.06/02/2026SE
K252524Quadsense (Quadsense and Quadsense Pro)ONN · Special Eventum Orthopaedics, Ltd.09/09/2025SE
K241298QuadsenseONN · Traditional Eventum Orthopaedics, Ltd.10/04/2024SE
K242616Lantern® HipONN · Special Orthalign, Inc.10/03/2024SE
K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm…ONN · Traditional Orthosensor, Inc.08/25/2020SE
K200665VERASENSE for Stryker TriathlonONN · Special Orthosensor, Inc.04/12/2020SE
K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…ONN · Traditional Orthosensor, Inc.04/01/2020SE
K180459VERASENSE for Zimmer Biomet PersonaONN · Traditional Orthosensor, Inc.06/07/2018SE
K162237XO1 Knee Balancing SystemONN · Traditional Xpandortho, Inc.04/25/2017SE

Questions and answers

When was TrueBalance™ Surgical System cleared by the FDA?

TrueBalance™ Surgical System (K220830) received a 510(k) decision of Substantially Equivalent on September 15, 2022, 177 days after the submission was received.

What is the product code of K220830?

The FDA product code is ONN – Intraoperative Orthopedic Joint Assessment Aid, a Class II (moderate risk) device regulated under 21 CFR 882.4560.