Cleared Special

K231585 - Vantage PSI System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K231585 · 3D Systems, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2023
Decision
30d
Days
Class 2
Risk

K231585 is an FDA 510(k) clearance for the Vantage PSI System. Classified as Ankle Arthroplasty Implantation System (product code OYK), Class II - Special Controls.

Submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on June 30, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all 3D Systems, Inc. devices

Submission Details

510(k) Number K231585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OYK Ankle Arthroplasty Implantation System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - OYK Ankle Arthroplasty Implantation System

Devices cleared under the same product code (OYK) and FDA review panel - the closest regulatory comparables to K231585.
Salto Talaris Ankle PSI System
K243173 · 3D Systems, Inc. · Oct 2024
Cadence Ankle PSI System
K243174 · 3D Systems, Inc. · Oct 2024
Salto Talaris Ankle PSI System
K241148 · 3D Systems, Inc. · Aug 2024
Cadence Ankle PSI System
K241326 · 3D Systems, Inc. · Aug 2024
Axiom PSR System
K223326 · Restor3d · Mar 2023