Cleared Traditional

Vantage PSI System

K193432 · 3D Systems · Orthopedic

Nov 2020

Decision

335d

Days

Class 2

Risk

About This 510(k) Submission

K193432 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 (Littleton, US). The FDA issued a Cleared decision on November 9, 2020, 335 days after receiving the submission on December 10, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3110.

Submission Details

510(k) Number	K193432 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2019
Decision Date	November 09, 2020
Days to Decision	335 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.