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FDA 510(k)

Kinos Axiom Total Ankle System

K-Number: K232595 · 2023-11-28

ApplicantRestor3D
Decision Date2023-11-28
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kinos Axiom Total Ankle System is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K232595. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kinos Axiom Total Ankle System?

Kinos Axiom Total Ankle System is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Restor3D. The 510(k) number is K232595.

When did Kinos Axiom Total Ankle System receive FDA 510(k) clearance?

Kinos Axiom Total Ankle System received FDA 510(k) clearance on 2023-11-28, under 510(k) number K232595.

Who is the listed applicant for Kinos Axiom Total Ankle System?

The FDA 510(k) record lists Restor3D as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kinos Axiom Total Ankle System?

The FDA product code for Kinos Axiom Total Ankle System is HSN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07563803The restor3d Outcomes RegistryNOT_YET_RECRUITING

Other records listing Restor3D as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260556Veritas Shoulder SystemK253992Veritas Reverse Total Shoulder SystemK252067Velora Acetabular SystemK252454Kinos Total Ankle SystemK243643restor3d Reverse Total Shoulder Arthroplasty SystemK243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System

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Related Devices (Code: HSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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