Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Kinos Total Ankle System

K-Number: K241482 · 2024-07-22

ApplicantRestor3D
Decision Date2024-07-22
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Kinos Total Ankle System is a medical device manufactured by Restor3D. It received FDA 510(k) clearance on 2024-07-22 under approval number K241482. 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 Total Ankle System?

Kinos Total Ankle System is a medical device that received FDA 510(k) clearance on 2024-07-22. It is manufactured by Restor3D. The 510(k) number is K241482.

When was Kinos Total Ankle System approved by the FDA?

Kinos Total Ankle System received FDA 510(k) clearance on 2024-07-22, under approval number K241482.

What company makes Kinos Total Ankle System?

Kinos Total Ankle System is manufactured by Restor3D.

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

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

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Restor3D

K193491restor3d Metallic Interference Screw K220523restor3d TiDAL Lumbar Interbody Fusion Device K211789restor3d Pin Implants K232595Kinos Axiom Total Ankle System K231458Extremity Staple K223326Axiom PSR System

View all 12 devices →

Related Devices (Code: HSN)

K153452Salto XT, Salto TalarisTornier S.A.S. K153008INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K152217Exactech Vantage Total Ankle SystemExactech, Inc. K171004Hintermann Series H2 Total Ankle SystemDt Medtech, LLC K171067INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc K170968PROPHECY INVISION Pre-operative Navigation SystemWrightmedicaltechnologyinc

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.

↑