Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Klassic Knee System

K-Number: K162422 · 2016-10-28

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2016-10-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic Knee System is a medical device manufactured by Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-10-28 under approval number K162422. 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 2016-10-28. It is manufactured by Total Joint Orthopedics, Inc.. The 510(k) number is K162422.

When was Klassic Knee System approved by the FDA?

Klassic Knee System received FDA 510(k) clearance on 2016-10-28, under approval number K162422.

What company makes Klassic Knee System?

Klassic Knee System is manufactured by Total Joint Orthopedics, Inc..

What is the FDA product code for Klassic Knee System?

The FDA product code for Klassic Knee System is JWH.

Other Devices by Total Joint Orthopedics, Inc.

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, Porous K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® Poly K180929Klassic HD® Hip System K180159Klassic® Knee System 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

View all 11 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 K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P. K162222GENflex2 Total Knee SystemStelkast, Inc.

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.

↑