Cleared Special

Kinos Total Ankle System

K252454 · Restor3d · Orthopedic

Sep 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K252454 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 September 3, 2025, 30 days after receiving the submission on August 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K252454 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2025
Decision Date	September 03, 2025
Days to Decision	30 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