EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202270 FDA 510(k)
- FDA Product Code
- KCT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device is an accessory designed to organize, enclose, reprocess, transport and store the Stryker Mako Total Knee with Triathlon system. It functions as a containment device that supports handling of the knee implant components within healthcare facilities.
The device is supplied for use in conjunction with a legally marketed, validated, FDA‑cleared sterile barrier system and is not sterile on its own. It received FDA 510(k) clearance (K202270) on 2020‑12‑02, is classified under product code KCT, and was reviewed by the HO advisory panel.
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: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device, EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device, PDF December 2, 2020 K1 Medical LLC ℅ Joseph Azary Regulatory Consultant ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202270 | Class II | Active |
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Manufacturer
- Manufacturer
- K1 Medical, LLC
Sources (1)
- FDA 510(k) K202270 24 fields · synced Sep 19, 2026