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FDA 510(k)

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

K-Number: K162256 · 2016-10-27

ApplicantTotal Joint Orthopedics, Inc.
Decision Date2016-10-27
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is a medical device manufactured by Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2016-10-27 under approval number K162256. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is a medical device that received FDA 510(k) clearance on 2016-10-27. It is manufactured by Total Joint Orthopedics, Inc.. The 510(k) number is K162256.

When was Klassic Femur, Porous, Klassic Tibial Baseplate, Porous approved by the FDA?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous received FDA 510(k) clearance on 2016-10-27, under approval number K162256.

What company makes Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is manufactured by Total Joint Orthopedics, Inc..

What is the FDA product code for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous?

The FDA product code for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous is MBH.

Related Clinical Trials

NCT04389749 Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Other Devices by Total Joint Orthopedics, Inc.

K162422Klassic Knee System 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: MBH)

K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, Inc. K171991EMPOWR Porous Knee SystemEncore 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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