Identifiers
- 510(k) Number
- K170581 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 computer-assisted orthopedic surgical system designed for planning and guiding total knee arthroplasty (TKA). It integrates robotic technology to enhance precision in joint replacement procedures, enabling surgeons to achieve accurate implant positioning and alignment based on patient-specific anatomical data.
This device is used in operating rooms for preoperative planning and intraoperative guidance during total knee arthroplasty. Supplied as a sterile, single-use or reusable system (as applicable to components), it adheres to FDA 510(k) clearance under the Special review pathway (K170581). The system is intended for use in MRI-safe environments where applicable components meet relevant safety standards, though specific MRI compatibility details must be verified per device specifications.
Frequently asked questions
What is the Mako Total Knee Application used for?
The Mako Total Knee Application is a computer-assisted surgical system designed specifically for total knee arthroplasty (TKA). It combines robotic technology with preoperative planning to help surgeons achieve precise implant positioning and alignment tailored to each patient’s unique anatomy. This reduces variability in outcomes and supports more accurate joint replacement procedures.
Is the Mako Total Knee Application sterile and single-use?
The Mako Total Knee Application is supplied as either a sterile single-use or reusable system, depending on the specific components involved. Sterility ensures safety during surgery, while the modular design allows for flexibility in how components are utilized—either discarded after a single procedure or reprocessed for reuse, as per manufacturer guidelines. Always follow the manufacturer’s instructions for handling and reprocessing reusable parts.
Can the Mako Total Knee Application be used in MRI-safe environments?
The system is intended for use in MRI-safe environments, but MRI compatibility depends on the specific components within the Mako Total Knee Application. Not all parts may be MRI-safe, so it’s critical to verify the compatibility of the exact components being used against the manufacturer’s specifications before proceeding. Always consult the device documentation for detailed MRI safety information.
What regulatory pathway does the Mako Total Knee Application follow?
The Mako Total Knee Application received FDA clearance under the 510(k) pathway, specifically through the Special Review pathway (K170581). This pathway is used for devices that may present higher risks or require additional scrutiny, ensuring thorough evaluation of safety and effectiveness before market authorization. The clearance confirms the device is substantially equivalent to a legally marketed predicate device.
How does the Mako Total Knee Application enhance surgical precision in total knee replacements?
The system enhances precision by integrating robotic-assisted technology with patient-specific anatomical data collected during preoperative planning. Surgeons use this data to guide intraoperative cuts and implant placement, reducing human error and improving alignment accuracy. The result is a more consistent and reproducible outcome, which can contribute to better long-term joint function and patient satisfaction.
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 Surgical Corp. FDA 510 (k) Orthopedic Products - Latest 2026, Mako Total Knee 2.0 | Stryker, Mako Total Knee Application by MAKO Surgical Corp. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170581 | Class II | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
Sources (1)
- FDA 510(k) K170581 24 fields · synced Oct 1, 2026