K212411 - Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
(FDA 510(k) Clearance)

K212411 is an FDA 510(k) clearance for the Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS), a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Conformis, Inc. (Billerica, US). The FDA issued a Cleared decision on September 23, 2021, 51 days after receiving the submission on August 3, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.