Cleared Traditional

K193432 - Vantage PSI System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193432 · 3D Systems · Orthopedic device
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Nov 2020
Decision
335d
Days
Class 2
Risk

K193432 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 (Littleton, US). The FDA issued a Cleared decision on November 9, 2020 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K193432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 122d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K193432.
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
Vantage PSI System
K231585 · 3D Systems, Inc. · Jun 2023
Axiom PSR System
K223326 · Restor3d · Mar 2023