VERASENSE for Zimmer Biomet Persona

FDA 510(k) K180459 · Orthosensor, Inc.

Substantially Equivalent

510(k) numberK180459

Submission

Device name
VERASENSE for Zimmer Biomet Persona
Applicant
Orthosensor, Inc.
Dania Beach, FL, US
Received
February 20, 2018
Decision date
June 7, 2018
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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K262253Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)ONN · Special Orthalign, Inc.07/31/2026SE
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
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
K162237XO1 Knee Balancing SystemONN · Traditional Xpandortho, Inc.04/25/2017SE

More from Xpandortho, Inc.

510(k)DeviceDecision
K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm…ONN · Traditional 08/25/2020SE
K200665VERASENSE for Stryker TriathlonONN · Special 04/12/2020SE
K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…ONN · Traditional 04/01/2020SE
K150372VERASENSE Knee SystemONN · Traditional 04/15/2016SE
K131767Orthosensor Knee Balancer, Verasense Knee SystemONN · Special 11/08/2013SE
K130380Orthosensor Knee BalancerONN · Special 06/13/2013SE
K090474Orthorex Intra-Operative Load SensorONN · Traditional 10/19/2009SE

Questions and answers

When was VERASENSE for Zimmer Biomet Persona cleared by the FDA?

VERASENSE for Zimmer Biomet Persona (K180459) received a 510(k) decision of Substantially Equivalent on June 7, 2018, 107 days after the submission was received.

What is the product code of K180459?

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