Cleared Traditional

K232595 - Kinos Axiom Total Ankle System

K232595 is an FDA 510(k) clearance for Kinos Axiom Total Ankle System, manufactured by Restor3d. The device is a Class 2 Orthopedic device with product code HSN cleared through the Traditional 510(k) pathway after a 95-day FDA review.

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

FDA 510(k) Submission Details - K232595

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.

HSN Device Classification - Class 2, Special Controls

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 58
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