Use Instructions

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4. DEVICE SYSTEM DESCRIPTION

The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) is a

system that combines physical components, electronics, software, and user interfaces to collect,

store, analyze, transmit, and display patient data for use by both physicians and patients. Table

3 lists the components and interfaces of the CTE with CHIRP System.

Table 3: CTE with CHIRP System Components

Component or

Interface

Description

Model Number or

Catalogue

Number

CTE Implant

14mm (D) x 58mm (H)

Tibial Extension with internal electronics and

software which allows it to collect kinematic

data in addition to providing stability to the

patient’s knee prosthesis

43-5570-058-14

CTE 14mm x 58mm X-

Ray Template

Used to preoperatively determine if the

patient’s anatomy is appropriate for a CTE

implant

43-5570-004-14

Surgical

Instrumentation

CTE Impaction Sleeve

43-5399-001-14

5 deg Left Tibial Resection Cutting Guide 43-5399-051-05

5 deg Right Tibial Resection Cutting Guide 43-5399-052-05

Drill Bit 43-5399-058-14

CTE Provisional 43-5571-058-14

OR Base Station System OR Base Station unit 43-5570-002-14

Dedicated Laptop PC 43-5570-003-14

Physician Instructions for Use

DRAFT