Cleared Traditional

Axiom PSR System

K223326 · Restor3d · Orthopedic

Mar 2023

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K223326 is an FDA 510(k) clearance for the Axiom PSR System, a Ankle Arthroplasty Implantation System (Class II — Special Controls, product code OYK), submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on March 30, 2023, 150 days after receiving the submission on October 31, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K223326 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2022
Decision Date	March 30, 2023
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OYK — Ankle Arthroplasty Implantation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3110
Definition	Intended To Be Used To Assist In The Implantation Of A Specific Ankle Arthroplasty Device. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, And Sizing.