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Canturio Smart Extension

FDA 510(k)

Class II (US FDA 510(k))

510(k) K234056

by Canary Medical Usa Llc

Identifiers

510(k) Number
K234056 FDA 510(k)
FDA Product Code
QPP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3600 FDA 510(k)
Regulation Number
888.3600 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Canturio Smart Extension is an implantable post-surgical kinematic measurement knee device. It is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty post-surgical care.

The device is supplied as part of the Canturio Smart Extension with CHIRP System. It is a prescription device authorized under FDA 510(k) clearance (K234056) and is classified as a Class II medical device under regulation number 888.3600 for orthopedic use.

Frequently asked questions

What is the Canturio Smart Extension used for?

The Canturio Smart Extension is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty post-surgical care, enabling clinicians to monitor joint movement and recovery objectively after surgery.

How is the Canturio Smart Extension supplied and what system does it work with?

The device is supplied as part of the Canturio Smart Extension with CHIRP System, meaning it is provided as an integrated implantable sensor system designed to wirelessly transmit kinematic data from the knee implant to external monitoring equipment for post-operative assessment.

Is the Canturio Smart Extension a single-use or reusable device?

The Canturio Smart Extension is an implantable device intended for long-term use within the body following total knee arthroplasty; it is not designed for removal or reuse after implantation, as it remains embedded to continuously monitor kinematic data throughout the post-surgical care period.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF CANARY canturio® Smart Extension with CHIRP® System, canturio® se (Canturio Smart Extension) (K234056) — FDA 510 (k ..., Surgical Technique Smart Extension - Canary Medical, canturio® se (Canturio Smart Extension) (K234056) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Canary Medical Usa Llc
FDA Applicant
Canary Medical USA, LLC

Sources (1)

  • FDA 510(k) K234056 24 fields · synced Oct 1, 2026