Use Instructions

OrthoSensor, Inc.
1855 Griffin Road
Suite A-310
Dania Beach, FL 33004-2200 USA
www.orthosensor.com
LB-5190 Rev. 6 (EN) 1
08-2020
For further information, contact the OrthoSensor Customer Service Center by phone at + 1 954-577-7770 or by e-mail
at [e-mail] or go to www.orthosensor.com.
VERASENSE INSTRUCTIONS FOR USE
DESCRIPTION
VERASENSE provides a means for orthopedic surgeons to dynamically balance the knee during primary or revision Total Knee
Arthroplasty (TKA).
The VERASENSE device is an intelligent disposable tibial insert that measures dynamic loads in the medial and lateral
compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI or LinkStation MINI
Evaluation Kit with VERASENSE Software Application (VSA) installed for surgeon visualization. Individual VERASENSE devices are
packaged sterile, for single patient use with a Shim Set for thickness adjustments.
NOTE: The following accessories are necessary for the operation of the VERASENSE device:
• LinkStation MINI or LinkStation MINI Evaluation Kit
• VERASENSE Software Application (VSA)
The LinkStation MINI and LinkStation MINI Evaluation Kit displays the measured load data by providing a graphical and
numerical presentation of the loads in both the medial and lateral compartments of the knee.
VERASENSE devices are implant system specific due to variations in implant design. VERASENSE is compatible with the
following implant systems:
• VERASENSE for Biomet Vanguard
• VERASENSE for Stryker Triathlon
• VERASENSE for Zimmer NexGen
• VERASENSE for Smith & Nephew Legion
• VERASENSE for Smith & Nephew Journey II
• VERASENSE for Zimmer Biomet Persona
Please see Table 3 for the listing of Catalog Numbers for each compatible implant system and sizes.
INDICATIONS
VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be
indicated.
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. VERASENSE is
sterile, for single patient use.
CONTRAINDICATIONS
• Any active or suspected latent infection in or about the knee joint.
• Refer to Implant Knee System IFU for additional contraindications.
WARNINGS
• The internal components of the VERASENSE devices have not been shown to be sterile. Immediately discontinue use of
device if any cracks, damage, or internal fluid is observed. Failure to observe these warnings may expose patient to non-
sterile material.
• The VERASENSE device consists of sophisticated calibrated internal microelectronics. Do NOT utilize excessive force or
impact VERASENSE devices directly with a mallet. Excessive impaction force may damage or negatively impact function of the
VERASENSE.
• Handle VERASENSE device with care when inserting, adjusting shim size or removing from tibial tray.
• Do not forcibly impact femoral implant trial onto the VERASENSE device placed in tibial tray.