Use Instructions

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5. INTENDED USE
5.1. Intended Use
The CTE with CHIRP System is intended to provide objective kinematic data while providing
additional stability afforded by a traditional tibial extension. The implanted medical device is
used to assist the patient and the physician during a patient’s TKA post-surgical care. The
kinematic data is intended as an adjunct to standard of care and physiological parameter
measurement tools applied or utilized by the physician during the course of patient monitoring
and treatment post-surgery.
5.2. Indications for Use
The Canary Tibial Extension implant is indicated for use with the Zimmer Persona® Personalized
Knee System for total knee arthroplasty (TKA) in patients with severe knee pain and disabilities
due to:
Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis
Collagen disorders, and/or avascular necrosis of the femoral condyle
Post-traumatic loss of joint configuration, particularly when there is patellofemoral
erosion, dysfunction or prior patellectomy
Moderate valgus, varus, or flexion deformities
The salvage of previously failed surgical attempts or for a knee in which satisfactory
stability in flexion cannot be obtained at the time of surgery.
The Canary Tibial Extension with CHIRP System may be used in any instance where additional,
objective, kinematic data on total knee replacement function is beneficial to the implant care
process as determined by the physician.
This device is intended to be used with cemented knee constructs.
5.3. Users and Component Interfaces
The CTE with CHIRP System is intended to provide objective kinematic data on the patient’s
activity level and total knee arthroplasty (TKA) function. The OR Base Station System is used to
set up, test, and activate the CTE Implant before implantation. It is also used to associate the
CTE to the specific patient by recording serial number information for the CTE Implant and
associated Zimmer Biomet Persona® Personalized Knee System components. The OR Base
Station System transmits these data to the Canary Cloud Data Management Platform linked to
the Patient’s account.
Physician Instructions for Use
DRAFT