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Mako Surgical Unicondylar Knee System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060017

by MAKO Surgical Corp.

Identifiers

510(k) Number
K060017 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 Unicondylar Knee System is a single‑use orthopedic implant designed for cemented reconstruction of either the medial or lateral femoral condyle and the matching tibial surface. It is intended for patients with moderate disability or pain from osteoarthritis or traumatic arthritis when sufficient bone is available to seat the implant.

The system is supplied as a sterile, single‑use device and is cleared under FDA 510(k) traditional clearance (K060017, product code HSX) as substantially equivalent to a predicate device. It is used in cemented knee resurfacing procedures, requiring adequate bone stock, and is regulated as a Class II medical device in the United States.

Frequently asked questions

What is the MAKO SURGICAL UNICONDYLAR KNEE SYSTEM used for?

It is designed for cemented reconstruction of either the medial or lateral femoral condyle and the matching tibial surface in patients with moderate disability or pain from osteoarthritis or traumatic arthritis when sufficient bone is available to seat the implant.

Is the MAKO SURGICAL UNICONDYLAR KNEE SYSTEM sterile and single-use?

Yes, the system is supplied as a sterile, single-use device, meaning it is intended for one procedure only and must not be reprocessed or reused to maintain sterility and performance integrity.

What regulatory pathway was used for the MAKO SURGICAL UNICONDYLAR KNEE SYSTEM?

It received FDA 510(k) traditional clearance under K060017 with product code HSX, demonstrating substantial equivalence to a predicate device, and is regulated as a Class II medical device in the United States.

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 UNICONDYLAR KNEE SYSTEM (K060017) — FDA 510(k ..., PDF Mako Partial Knee Medial unicondylar resurfacing - Tekno Surgical, Mako SmartRobotics Overview | Stryker, Modification To:Mako Surgical Unicondylar Knee System

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) K060017 24 fields · synced Sep 28, 2026