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FDA 510(k)

Active-X Total Knee System

K-Number: K160159 · 2016-09-06

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2016-09-06
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Active-X Total Knee System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-06 under approval number K160159. 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 Active-X Total Knee System?

Active-X Total Knee System is a medical device that received FDA 510(k) clearance on 2016-09-06. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K160159.

When was Active-X Total Knee System approved by the FDA?

Active-X Total Knee System received FDA 510(k) clearance on 2016-09-06, under approval number K160159.

What company makes Active-X Total Knee System?

Active-X Total Knee System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for Active-X Total Knee System?

The FDA product code for Active-X 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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