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FDA 510(k)

World Total Knee System

K-Number: K223062 · 2022-11-04

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2022-11-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

World Total Knee System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2022-11-04 under approval number K223062. 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 Total Knee System?

World Total Knee System is a medical device that received FDA 510(k) clearance on 2022-11-04. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K223062.

When was World Total Knee System approved by the FDA?

World Total Knee System received FDA 510(k) clearance on 2022-11-04, under approval number K223062.

What company makes World Total Knee System?

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

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

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

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 NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING

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: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 39150225 Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases. Journal of comparative effectiveness research (2024)

Other Devices by Signature Orthopaedics Pty, Ltd.

K160159Active-X Total Knee System K161155Origin Coxa Vara Hip Stem K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner K172019Brisbane ALIF Device, Gladstone ALIF Device K172020Arlington PLIF/TLIF Cage K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System

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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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