Quadsense

FDA 510(k) K241298 · Eventum Orthopaedics, Ltd.

Substantially Equivalent

510(k) numberK241298

Submission

Device name
Quadsense
Applicant
Eventum Orthopaedics, Ltd.
Leeds, GB
Received
May 8, 2024
Decision date
October 4, 2024
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.

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K252524Quadsense (Quadsense and Quadsense Pro)ONN · Special Eventum Orthopaedics, Ltd.09/09/2025SE
K242616Lantern® HipONN · Special Orthalign, Inc.10/03/2024SE
K220830TrueBalance™ Surgical SystemONN · Traditional These Three Medical, LLC09/15/2022SE
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

More from Xpandortho, Inc.

510(k)DeviceDecision
K252524Quadsense (Quadsense and Quadsense Pro)ONN · Special 09/09/2025SE

Questions and answers

When was Quadsense cleared by the FDA?

Quadsense (K241298) received a 510(k) decision of Substantially Equivalent on October 4, 2024, 149 days after the submission was received.

What is the product code of K241298?

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