Cleared Special

Vantage PSI System

K231585 · 3D Systems, Inc. · Orthopedic
Jun 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K231585 is an FDA 510(k) clearance for the Vantage PSI System, a Ankle Arthroplasty Implantation System (Class II — Special Controls, product code OYK), submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on June 30, 2023, 30 days after receiving the submission on May 31, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number K231585 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2023
Decision Date June 30, 2023
Days to Decision 30 days
Submission Type Special
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.