Summary
FDA granted De Novo authorization DEN200064 for the Canary Tibial Extension with CHIRP reporting system on August 27, 2021. Subsequent 510(k) decisions include the 30mm canturio smart extension under K234056 on April 24, 2024. The technology is compatible with Zimmer Biomet’s Persona knee system. [9][11]
The kinematic measurements supplement other monitoring tools after knee replacement. FDA labeling states that these data are not intended to support clinical decision-making and have not been shown to provide clinical benefit; Canary repeats that limitation on its clinician page. [9][4]
FDA lists an open Class II recall, Z-2099-2025, for incorrectly labeled Canturio Smart Extension implants, model 43-5570-030-14. The action concerns specified serials within lots AJ327, AJ330 and AJ592, with 106 units distributed in Indiana. It was initiated May 2, 2025; affected stock was to be retrieved and returned. The record does not describe a recall of the entire Persona IQ platform. [13]
The lumbar cartridge and cardiac auscultation sensor remain development programs. Breakthrough Device designation for the spine application is distinct from marketing authorization; the cardiac program’s 2024 feasibility report describes two patients treated in Paraguay. [7][6]
