Cleared Traditional

EVOLUTION? Tibial Cones

K233507 · Microport Orthopedics, Inc. · Orthopedic
Jan 2024
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K233507 is an FDA 510(k) clearance for the EVOLUTION? Tibial Cones, a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on January 18, 2024, 79 days after receiving the submission on October 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number K233507 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2023
Decision Date January 18, 2024
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3565

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