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QPPClass II

Implantable Post-Surgical Kinematic Measurement Knee Device

21 CFR 888.3600 / Orthopedic

QPP is the FDA product code for Implantable Post-Surgical Kinematic Measurement Knee Device, a class II device type, regulated under 21 CFR 888.3600. FDA's definition for this code 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 physiological parameter measurement tools utilized during the course of patient monitoring...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QPP
Device name
Implantable Post-Surgical Kinematic Measurement Knee Device
FDA 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.
Regulation
21 CFR 888.3600
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code QPP

By decision year
4 clearances under product code QPP with a decision year between 2021 and 2024, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QPP by decision year
YearClearances
20211
20221
20231
20241

Applicants with the most clearances

Product code QPP
Applicants holding the most 510(k) clearances under product code QPP
ApplicantClearances
Canary Medical USA LLC4

Companies listing this code with FDA

Companies whose registered establishments list this code