Cleared Traditional

Kinos Axiom Total Ankle System (K232595) - FDA 510(k) Clearance

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

K232595 · Restor3d · Orthopedic device
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Nov 2023
Decision
95d
Days
Class 2
Risk

K232595 is an FDA 510(k) clearance for the Kinos Axiom Total Ankle System. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on November 28, 2023 after a review of 95 days - within the typical 510(k) review window.

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 K232595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2023
Decision Date November 28, 2023
Days to Decision 95 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
27d faster than avg
Panel avg: 122d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
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 - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 55
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K232595.
APEX 3D Total Ankle Replacement System
K240259 · Paragon 28, Inc. · Jun 2024
restor3d Kinos Axiom Total Ankle System
K240591 · Restor3D, Inc. · Apr 2024
QUANTUM® Patient Specific Instrumentation (PSI) System
K231699 · In2bones Sas · Apr 2024
Exactech® Vantage® Total Ankle System
K230717 · Exactech, Inc. · Oct 2023
Vantage® Total Ankle System
K232002 · Exactech, Inc. · Sep 2023
OPTIX H2 Patient Specific Instrument System
K230462 · Vilex, LLC · Jul 2023