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FDA 510(k)

Klassic Knee System - Revision Tibial Baseplate

K-Number: K243991 · 2025-03-24

ApplicantTotal Joint Othopedics, Inc.
Decision Date2025-03-24
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic Knee System - Revision Tibial Baseplate is a medical device manufactured by Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2025-03-24 under approval number K243991. 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 Klassic Knee System - Revision Tibial Baseplate?

Klassic Knee System - Revision Tibial Baseplate is a medical device that received FDA 510(k) clearance on 2025-03-24. It is manufactured by Total Joint Othopedics, Inc.. The 510(k) number is K243991.

When was Klassic Knee System - Revision Tibial Baseplate approved by the FDA?

Klassic Knee System - Revision Tibial Baseplate received FDA 510(k) clearance on 2025-03-24, under approval number K243991.

What company makes Klassic Knee System - Revision Tibial Baseplate?

Klassic Knee System - Revision Tibial Baseplate is manufactured by Total Joint Othopedics, Inc..

What is the FDA product code for Klassic Knee System - Revision Tibial Baseplate?

The FDA product code for Klassic Knee System - Revision Tibial Baseplate is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING

Other Devices by Total Joint Othopedics, Inc.

K161073Klassic HD Hip System K171962Klassic HD® Hip System K191399BIOLOX CONTOURA Ceramic Femoral Head K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K230537Klassic Knee Revision System

View all 7 devices →

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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