Identifiers
- 510(k) Number
- K172219 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mako Total Knee Application is a device intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. It is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified.
The Mako Total Knee Application is supplied with FDA 510(k) authorizations. The device is designed for use in orthopedic procedures, specifically for surgical knee procedures, and is available with a product code of OLO. The device has undergone a traditional clearance process, with a decision date of 2017-09-21, and has been assigned a k number of K172219.
Frequently asked questions
What is the Mako Total Knee Application used for?
The Mako Total Knee Application is used to assist surgeons in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic knee procedures.
Is the Mako Total Knee Application supplied sterile?
The description does not specify if the Mako Total Knee Application is supplied sterile, but it is designed for use in orthopedic procedures and has undergone a traditional clearance process.
What is the product code for the Mako Total Knee Application?
The product code for the Mako Total Knee Application is OLO.
What type of clearance does the Mako Total Knee Application have?
The Mako Total Knee Application has a traditional clearance with a decision date of 2017-09-21 and has been assigned a k number of K172219.
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: Mako Total Knee - Stryker, Mako Total Knee Application (K241011) — FDA 510(k) | Innolitics, Mako Total Knee 2.0 | Stryker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172219 | Class II | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
Sources (1)
- FDA 510(k) K172219 24 fields · synced Sep 24, 2026