Cleared Traditional

Kinos Total Ankle System

K241482 · Restor3d · Orthopedic

Jul 2024

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K241482 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 July 22, 2024, 59 days after receiving the submission on May 24, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K241482 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2024
Decision Date	July 22, 2024
Days to Decision	59 days
Submission Type	Traditional
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