FDA 510(k)

Klassic Knee System

K-Number: K211602 · 2021-07-23

Decision Date2021-07-23

Product CodeJWH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Klassic Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-07-23 under 510(k) number K211602. 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?

Klassic Knee System is a medical device that received FDA 510(k) clearance on 2021-07-23. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K211602.

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

Klassic Knee System received FDA 510(k) clearance on 2021-07-23, under 510(k) number K211602.

Who is the listed applicant for Klassic Knee System?

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

What is the FDA product code for Klassic Knee System?

The FDA product code for Klassic Knee System is JWH.

Other records listing Total Joint Orthopedics, 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.

K261734Klassic Infection Spacer System K220483Platform® Acetabular System K211877Klassic Knee System K202740Klassic Knee System Tibial Inserts, PS-Max K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly

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Related Devices (Code: JWH)

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 UC K261032NovoKnee (SteriKnee)NovoSource K253793Materialise 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.