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FDA 510(k)

World Knee Total Knee Systems

K-Number: K190577 · 2019-11-27

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2019-11-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

World Knee Total Knee Systems is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2019-11-27 under approval number K190577. 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 World Knee Total Knee Systems?

World Knee Total Knee Systems is a medical device that received FDA 510(k) clearance on 2019-11-27. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K190577.

When was World Knee Total Knee Systems approved by the FDA?

World Knee Total Knee Systems received FDA 510(k) clearance on 2019-11-27, under approval number K190577.

What company makes World Knee Total Knee Systems?

World Knee Total Knee Systems is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for World Knee Total Knee Systems?

The FDA product code for World Knee Total Knee Systems is JWH.

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Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41810241 Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance. Frontiers in medicine (2026) PMID: 41568227 A frugal arduino-based spirometer for low-resource settings: design, development and validation of a preliminary prototype. Frontiers in bioengineering and biotechnology (2025) PMID: 41407822 Do we need prequalification of AI as a medical device to drive equitable adoption. NPJ digital medicine (2025)

Other Devices by Signature Orthopaedics Pty, Ltd.

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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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