Cleared Special

Kinos Total Ankle System

K242868 · Restor3d · Orthopedic

Oct 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K242868 is an FDA 510(k) clearance for the Kinos Total Ankle System, a Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSN), submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on October 18, 2024, 28 days after receiving the submission on September 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K242868 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2024
Decision Date	October 18, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSN — Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110