KRQClass II

Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer

21 CFR 888.3550 / Orthopedic

KRQ is the FDA product code for Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer, a class II device type, regulated under 21 CFR 888.3550. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: KRQ
Device name: Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Regulation: 21 CFR 888.3550
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: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order

Recent clearances

Product code KRQ

FDA records hold no clearances under product code KRQ.

Recent recalls

Product code KRQ

Z-1778-2022Class IIA MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ...Howmedica Osteonics Corp. / initiated 2022-08-24 / 1 unit

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)