QPP

Implantable Post-Surgical Kinematic Measurement Knee Device

Product code
QPP
Device name
Implantable Post-Surgical Kinematic Measurement Knee Device
Device class
Class 2
21 CFR
21 CFR 888.3600
Medical specialty
Orthopedic
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
4

FDA classification definition

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 physiological parameter measurement tools utilized during the course of patient monitoring and treatment post-surgery.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-24.

NumberDecision dateApplicantDevice nameSummary
K2340562024-04-24Canary Medical USA, LLCcanturio® se (Canturio Smart Extension)PDF

1 summaries are archived here for direct download.

Official FDA classification page: QPP
Classification and pathway per current FDA publications. Data from openFDA (CC0).