VERASENSE for Stryker Triathlon

FDA 510(k) K200665 · Orthosensor, Inc.

Substantially Equivalent

510(k) numberK200665

Submission

Device name
VERASENSE for Stryker Triathlon
Applicant
Orthosensor, Inc.
Dania Beach, FL, US
Received
March 13, 2020
Decision date
April 12, 2020
Decision
Substantially Equivalent (SESE)
Type
Special 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

510(k)DeviceApplicantDecision
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
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
K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm…ONN · Traditional 08/25/2020SE
K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona…ONN · Traditional 04/01/2020SE
K180459VERASENSE for Zimmer Biomet PersonaONN · Traditional 06/07/2018SE
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 Stryker Triathlon cleared by the FDA?

VERASENSE for Stryker Triathlon (K200665) received a 510(k) decision of Substantially Equivalent on April 12, 2020, 30 days after the submission was received.

What is the product code of K200665?

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