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Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162256

by Total Joint Orthopedics, Inc.

Identifiers

510(k) Number
K162256 FDA 510(k)
FDA Product Code
MBH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3565 FDA 510(k)
Regulation Number
888.3565 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Klassic Femur, Porous, and Klassic Tibial Baseplate, Porous are components of the Klassic Knee System, designed for cementless total knee arthroplasty. The femoral component is made from Cobalt-Chromium-Molybdenum alloy with a cobalt chrome porous sintered coating, while the tibial baseplate is made from Titanium alloy with a titanium porous sintered coating.

The Klassic Femur, Porous, and Klassic Tibial Baseplate, Porous are available in various sizes to accommodate different patient anatomies. The device has received FDA 510K authorization, with a decision description of Substantially Equivalent. The Klassic Knee System offers a range of components, including seven sizes of femurs, six sizes of tibial inserts and baseplates, and five sizes of patellae.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Klassic® Knee System - TJO - Total Joint Orthopedics, Klassic Femur, Porous, Klassic Tibial Baseplate, Porous, PDF ART-MK91004H Klassic Knee System Info Sheet_F.indd

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Total Joint Orthopedics, Inc.

Sources (1)

  • FDA 510(k) K162256 24 fields · synced Oct 6, 2026