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FDA 510(k)

Klassic Knee Revision System

K-Number: K230537 · 2023-05-19

ApplicantTotal Joint Othopedics, Inc.
Decision Date2023-05-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic Knee Revision System is a medical device manufactured by Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2023-05-19 under approval number K230537. 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 Revision System?

Klassic Knee Revision System is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Total Joint Othopedics, Inc.. The 510(k) number is K230537.

When was Klassic Knee Revision System approved by the FDA?

Klassic Knee Revision System received FDA 510(k) clearance on 2023-05-19, under approval number K230537.

What company makes Klassic Knee Revision System?

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

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

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

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_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 K243991Klassic Knee System - Revision Tibial Baseplate

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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