Platform TCCK Total Knee
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K790762 FDA 510(k)
- FDA Product Code
- HRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3530 FDA 510(k)
- Regulation Number
- 888.3530 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer. It is a total knee replacement system designed for orthopedic use.
It was cleared via the FDA 510(k) pathway under K790762 with a traditional clearance and is classified as a Class II device. The product is supplied non-sterile and intended for reuse after appropriate cleaning and sterilization by the user. No MRI safety information, sizes, or storage conditions are specified in the data.
Frequently asked questions
What is the PLATFORM TCCK TOTAL KNEE used for?
The PLATFORM TCCK TOTAL KNEE is a total knee replacement system designed for orthopedic use, specifically as a femorotibial prosthesis to replace the knee joint in patients requiring total knee arthroplasty.
How is the PLATFORM TCCK TOTAL KNEE supplied and is it sterile?
The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user, meaning the healthcare facility must sterilize it prior to implantation.
What regulatory pathway was used for the PLATFORM TCCK TOTAL KNEE?
The PLATFORM TCCK TOTAL KNEE was cleared via the FDA 510(k) pathway under submission K790762 with a traditional clearance and is classified as a Class II medical device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K790762 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K790762 24 fields · synced Sep 21, 2026