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Mako Surgical Corporation Unicondylar Knee Implant System Iii

FDA 510(k)

Class II (US FDA 510(k))

510(k) K082081

by MAKO Surgical Corp.

Identifiers

510(k) Number
K082081 FDA 510(k)
FDA Product Code
HSX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3520 FDA 510(k)
Regulation Number
888.3520 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mako Surgical Corporation Unicondylar Knee Implant System Iii is a unicompartmental knee implant system, used in unicompartmental knee arthroplasty for conditions such as moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis. It is designed for cemented reconstruction of the medial or lateral femur and corresponding tibial surface.

The system is supplied as a single-use device and is intended for use in patients with sufficient bone to seat the implant. It has been cleared by the FDA, with a 510K clearance, and is classified under the product code HSX. The device is available in various sizes, although specific sizes are not listed in the provided data.

Frequently asked questions

What clinical condition is this implant intended to treat?

It is designed for unicompartmental knee arthroplasty in patients with moderately disabling joint disease caused by painful osteo‑ or post‑traumatic arthritis, targeting either the medial or lateral compartment of the knee.

Is the system supplied as a reusable or single‑use device?

The system is supplied as a single‑use device, meaning each implant is intended for one patient only and must be discarded after the procedure to maintain sterility and performance.

What fixation method does the implant use?

The implant is intended for cemented fixation, allowing the surgeon to secure the femoral and tibial components to the bone with surgical cement, which provides immediate stability.

What size options are available for this implant?

The device is offered in a range of sizes to accommodate different patient anatomies, although the exact size dimensions are not specified in the provided data.

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 Surgical Corporation Unicondylar Knee Implant System Iii, MAKO SURGICAL UNICONDYLAR KNEE SYSTEM - Innolitics, Mako Surgical Corporation Unicondylar Knee Implant System Iii

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
MAKO Surgical Corp.

Sources (1)

  • FDA 510(k) K082081 24 fields · synced Sep 23, 2026