Identifiers
- 510(k) Number
- K153075 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 total knee replacement. It features modular components, including femoral, tibial, and patellar implants, to restore function and alignment in patients with degenerative joint disease or trauma-related knee damage. The system is engineered to replicate natural knee mechanics, including adjustable tibial cuts to match the patient’s anatomical posterior slope, thereby minimizing impingement and instability during motion. Its design accommodates a range of anatomical variations through multiple component sizes, ensuring a tailored fit for diverse patient anatomies.
The Klassic Knee System is supplied as a sterile, single-use implant intended for surgical use in accredited orthopedic facilities. Components include seven femoral sizes, six tibial inserts and baseplates, and five patellar sizes, all compatible with the manufacturer’s proprietary fixation methods. The device is regulated under FDA 510(k) clearance (K153075) as substantially equivalent to a predicate device, adhering to orthopedic implant standards for sterility, biocompatibility, and structural integrity. Storage requires protection from moisture and contamination, as specified in the Instructions for Use (IFU), and components must be handled aseptically prior to implantation.
Frequently asked questions
What is the Klassic Knee System used for?
The Klassic Knee System is designed for primary total knee replacement in patients suffering from degenerative joint disease or trauma-related knee damage. Its modular components—femoral, tibial, and patellar implants—are engineered to restore natural knee mechanics, including adjustable tibial cuts to match the patient’s anatomical posterior slope. This customization helps minimize impingement and instability during movement, improving long-term function and comfort.
How is the Klassic Knee System supplied and prepared for surgery?
The Klassic Knee System is supplied as a sterile, single-use implant. Components must be handled aseptically before implantation to prevent contamination. The system includes seven femoral sizes, six tibial inserts and baseplates, and five patellar sizes, all compatible with the manufacturer’s proprietary fixation methods. Follow the Instructions for Use (IFU) for proper handling and preparation.
Is the Klassic Knee System reusable or single-use?
The Klassic Knee System is intended for single-use only. This ensures sterility and reduces the risk of infection or cross-contamination in surgical settings. Reuse is not recommended or supported by the manufacturer, as it may compromise the device’s structural integrity or sterility.
What storage requirements apply to the Klassic Knee System?
Components of the Klassic Knee System must be stored in a way that protects them from moisture and contamination. The Instructions for Use (IFU) provide specific storage guidelines to maintain sterility and functionality. Always handle components aseptically before surgery to prevent compromise of the implant’s integrity.
How does the modular design of the Klassic Knee System accommodate different patients?
The Klassic Knee System features a range of modular components—seven femoral sizes, six tibial inserts and baseplates, and five patellar sizes—to address anatomical variations. This flexibility allows surgeons to tailor the implant to each patient’s unique knee structure, ensuring a precise fit and improved alignment. Adjustable tibial cuts further enhance customization by matching the patient’s anatomical posterior slope.
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 IPAD-LB91008J Klassic Knee STM, PDF ART-LB90041AB Klassic Knee System Implant IFU
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K153075 | Class II | Active |
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Manufacturer
- Manufacturer
- Total Joint Orthopedics, Inc.
Sources (1)
- FDA 510(k) K153075 24 fields · synced Oct 1, 2026