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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 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 2023-05-19 under 510(k) 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. The listed applicant is Total Joint Othopedics, Inc.. The 510(k) number is K230537.

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

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

Who is the listed applicant for Klassic Knee Revision System?

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 Revision System?

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

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.

K243991Klassic Knee System - Revision Tibial BaseplateK232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostK213580Adapter 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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