Cleared Traditional

K223326 - Axiom PSR System (FDA 510(k) Clearance)

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

K223326 · Restor3d · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
150d
Days
Class 2
Risk

K223326 is an FDA 510(k) clearance for the Axiom PSR System. Classified as Ankle Arthroplasty Implantation System (product code OYK), Class II - Special Controls.

Submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on March 30, 2023 after a review of 150 days - an extended review cycle.

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

View all Restor3d devices

Submission Details

510(k) Number K223326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 122d · This submission: 150d
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 K223326.
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