Identifiers
- 510(k) Number
- K123339 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 TK1 Total Knee System is a Prosthesis, Knee, Patellofemoral, Semi-Constrained, Cemented, Polymer/Metal/Polymer, designed to replace damaged knee joints. It provides structural support and articulation for the knee, restoring mobility and function in patients with degenerative joint disease or trauma.
This system is supplied as a cemented implant and is intended for single-use in orthopedic surgical settings. It adheres to FDA 510(k) clearance (K123339) under the Traditional 510(k) pathway, with no third-party review. Compatibility with MRI is not specified, and storage conditions must align with manufacturer guidelines for orthopedic implants.
Frequently asked questions
What types of knee damage or conditions is the TK1 Total Knee System designed to address in patients?
The TK1 Total Knee System is specifically designed to replace damaged knee joints caused by degenerative joint disease or trauma. It provides structural support and articulation to restore mobility and function, making it suitable for patients who require a semi-constrained, cemented knee prosthesis.
Is the TK1 Total Knee System intended for reuse in surgical settings, or is it meant for single-use only?
The TK1 Total Knee System is explicitly intended for single-use in orthopedic surgical settings. It is supplied as a cemented implant and should not be reused after a single procedure.
What materials are used in the construction of the TK1 Total Knee System, and how is it secured in place?
The TK1 Total Knee System is composed of polymer/metal/polymer materials. It is a cemented implant, meaning it is secured in place using orthopedic bone cement during surgery.
How should the TK1 Total Knee System be stored according to manufacturer guidelines?
Storage conditions for the TK1 Total Knee System must follow manufacturer guidelines for orthopedic implants, though specific details like temperature or humidity requirements are not provided in the data. Always refer to Novosource’s instructions for proper handling and storage.
What regulatory pathway was followed for FDA clearance of the TK1 Total Knee System, and was there any third-party review involved?
The TK1 Total Knee System received FDA clearance under the Traditional 510(k) pathway (K123339) and was determined to be substantially equivalent to a predicate device. No third-party review was involved in this clearance process.
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: Tk1 Total Knee System 510 (k) FDA Premarket Notification K123339 ..., NovoSource Knee Product Portfolio | NovoSource, www.accessdata.fda.gov, Novosource Inc FDA Filings, NovoSource FDA 510 (k) Products - Latest 2026
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123339 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novosource, Inc.
Sources (1)
- FDA 510(k) K123339 24 fields · synced Sep 18, 2026