510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220413Substantially Equivalent

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

Canary Medical USA LLC, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220413 is the FDA 510(k) clearance record for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System, a class II device, cleared for Canary Medical USA, LLC on under FDA product code QPP (Implantable Post-Surgical Kinematic Measurement Knee Device). FDA's definition for product code QPP reads: "An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other...". FDA records list 4 510(k) clearances for Canary Medical USA, LLC, from to . As of , FDA records show no recalls naming K220413.

Clearance record

Decision date
Received
(128 days to decision)
Product code
QPP Implantable Post-Surgical Kinematic Measurement Knee Device
Regulation
21 CFR 888.3600
Device class
Class II
Review panel
Orthopedic
Applicant
Canary Medical USA, LLC 2710 Loker Ave. W., Suite 350, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPP

Trailing 12 months

FDA records hold no clearances under product code QPP in the trailing twelve months.

FDA records show no clearances under product code QPP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QPP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260