Cleared Traditional

Kinos Axiom Total Ankle System

K232595 · Restor3d · Orthopedic

Nov 2023

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K232595 is an FDA 510(k) clearance for the Kinos Axiom 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 November 28, 2023, 95 days after receiving the submission on August 25, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K232595 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	November 28, 2023
Days to Decision	95 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