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FDA 510(k)

Genius Total Knee System

K-Number: K170613 · 2017-07-17

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2017-07-17
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genius Total Knee System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2017-07-17 under approval number K170613. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genius Total Knee System?

Genius Total Knee System is a medical device that received FDA 510(k) clearance on 2017-07-17. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K170613.

When was Genius Total Knee System approved by the FDA?

Genius Total Knee System received FDA 510(k) clearance on 2017-07-17, under approval number K170613.

What company makes Genius Total Knee System?

Genius Total Knee System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Genius Total Knee System?

The FDA product code for Genius Total Knee System is JWH.

Related Clinical Trials

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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)

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Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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