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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 the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Othopedics, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) 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. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K243991.

When did Klassic Knee System - Revision Tibial Baseplate receive FDA 510(k) clearance?

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

Who is the listed applicant for Klassic Knee System - Revision Tibial Baseplate?

The FDA 510(k) record lists Total Joint Othopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT02521103Triathlon Tritanium Cone Augments Outcomes StudyACTIVE_NOT_RECRUITINGNCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITING

Other records listing Total Joint Othopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostK230537Klassic Knee Revision SystemK213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthK191399BIOLOX CONTOURA Ceramic Femoral HeadK171962Klassic HD® Hip SystemK161073Klassic HD Hip System

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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