Identifiers
- 510(k) Number
- K112906 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Klassic Knee System is a total knee arthroplasty device designed for primary knee replacement surgery. It features modular components, including femoral, tibial, and patellar implants, to restore joint function in patients with degenerative joint disease or trauma-related knee damage. The system is classified under orthopedic knee prostheses and is intended for use in total knee arthroplasty procedures.
The device is supplied as a modular set comprising seven femoral sizes, six tibial inserts and baseplates, and five patellar sizes to accommodate varying patient anatomies. It is intended for single-use and requires sterile handling prior to implantation. The Klassic Knee System holds an FDA 510(k) clearance under the Traditional review pathway, with a classification of substantially equivalent to a predicate device. Storage and handling must comply with standard orthopedic implant protocols to ensure sterility and integrity.
Frequently asked questions
What is the Klassic Knee System used for?
The Klassic Knee System is designed for primary total knee arthroplasty, meaning it replaces the damaged knee joint in patients suffering from degenerative joint disease or trauma-related knee damage. Its modular components—femoral, tibial, and patellar implants—allow for customization to restore joint function and mobility.
How is the Klassic Knee System supplied, and what sizes are available?
The system is supplied as a modular set, including seven femoral sizes, six tibial inserts and baseplates, and five patellar sizes. This variety ensures compatibility with a wide range of patient anatomies during surgery.
Is the Klassic Knee System intended for single-use or reuse?
The Klassic Knee System is intended for single-use only. Sterile handling is mandatory prior to implantation to maintain device integrity and prevent contamination, adhering to standard orthopedic implant protocols.
What regulatory clearance does the Klassic Knee System hold?
The Klassic Knee System holds FDA 510(k) clearance under the Traditional review pathway, classified as substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. regulatory standards for orthopedic knee prostheses.
How should the Klassic Knee System be stored and handled?
Storage and handling must follow standard orthopedic implant protocols to preserve sterility and device integrity. Proper packaging and environmental controls are essential to prevent damage or contamination before surgical use.
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® KNEE SYSTEM | Total Joint Orthopedics, PDF ART-LB90041AB Klassic Knee System Implant IFU, PDF ART-MK91004H Klassic Knee System Info Sheet_F.indd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112906 | Class II | Active |
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Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA 510(k) K112906 24 fields · synced Oct 1, 2026