Cleared Special

Identity? Imprint? CR KRS and Identity? Imprint? PS KRS

K231233 · Conformis, Inc. · Orthopedic
May 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K231233 is an FDA 510(k) clearance for the Identity? Imprint? CR KRS and Identity? Imprint? PS 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 May 26, 2023, 28 days after receiving the submission on April 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K231233 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2023
Decision Date May 26, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3560

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