Mako Total Knee Application

K170581 · Mako Surgical Corp. · OLO · May 11, 2017 · Neurology

Device Facts

• Record ID: K170581
• Device Name: Mako Total Knee Application
• Applicant: Mako Surgical Corp.
• Product Code: OLO · Neurology
• Decision Date: May 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Mako System 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 relative to a CT based model of the anatomy. These procedures include: - Total Knee Arthroplasty (TKA) The implant systems compatible with this system: - Triathlon Total Knee System (CR/CS/PS cemented Primary) - Kinetis Total Knee System (CR/UC)

Device Story

Mako System is a stereotactic instrument for orthopedic surgery; includes robotic arm, optical detector, computer, and planning software. Inputs: patient CT data. Operation: surgeon uses CT-based model for pre-surgical planning and intraoperative navigation; robotic arm acts as intelligent tool guide, providing passive haptic constraints via software-defined spatial boundaries. Used in OR by surgeons. Output: visual navigation and physical tool guidance. Benefits: assists in precise implant placement and anatomical preparation. Modification in K170581: addition of eRequest LifeCycle, an online portal for case management and file transfer during preoperative planning.

Clinical Evidence

No clinical data. Performance testing consisted of bench-level product specification verification and simulated-use validation of the eRequest LifeCycle preoperative planning workflow. All tests passed.

Technological Characteristics

Stereotactic robotic system; includes robotic arm, optical camera stand, cutting system, and planning laptop. Uses patient CT data for navigation. Software-defined spatial boundaries provide passive haptic constraints. Connectivity includes an online portal (eRequest LifeCycle) for case management and file transfer.

Indications for Use

Indicated for patients undergoing surgical knee procedures, specifically Total Knee Arthroplasty (TKA), where stereotactic surgery is appropriate and rigid anatomical bony structures can be registered to a CT-based model.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Mako Total Knee Application (K143752)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 11, 2017

MAKO Surgical Corp. Shikha Khandelwal Staff Regulatory Affairs Specialist 2555 Davie Rd Fort Lauderdale, Florida 33317

Re: K170581

Trade/Device Name: Mako Total Knee Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 27, 2017 Received: February 28, 2017

Dear Shikha Khandelwal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K170581

Device Name

Mako Total Knee Application

Indications for Use (Describe)

Indications for Use:

The Mako System is intended to assist the surgeon in providing software spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System 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 relative to a CT based model of the anatomy.

These procedures include:

- · Total Knee Arthroplasty (TKA)
The implants systems compatible with this system:

- · Triathlon Total Knee System (CR/CS/PS cemented Primary)
- · Kinetis Total Knee System (CR/UC)

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------------|
| <span style="display:inline-block; width:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="display:inline-block; width:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in a bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font below. Above the word "MAKO" is a blue, curved shape that resembles a wave or fin. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.

1555 Davie Road • Ft. Lauderdale, FL 3331 hone 954.927.2044 • Fax [phone] ww.makosurgical.com

510(K) SUMMARY

| Sponsor: | MAKO Surgical Corp.<br>2555 Davie Road, Fort Lauderdale, FL 33317 |
|------------------------|-----------------------------------------------------------------------------------------------------|
| Contact Person: | Shikha Khandelwal, PhD<br>[e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | February 24, 2017 |
| Proprietary Name: | Mako Total Knee Application |
| Common Name: | Total Knee Application (TKA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |

## Substantial Equivalence Claimed To:

The Mako Total Knee Application is substantially equivalent to the Mako Total Knee Application cleared via K143752.

Device Modification: An alternate online portal for case management and file transfer known as eRequest LifeCycle is being implemented for use during the preoperative planning workflow of the Mako Total Knee application.

## Description:

The Mako System with the Total Knee Application is a stereotactic instrument that includes a robotic arm, an integrated cutting system, an optical detector, a computer, dedicated instrumentation, operating software, a planning laptop, and tools and accessories.

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The system's architecture is designed to support total and partial knee procedures and total hip procedures. With application specific hardware and software, the system provides stereotactic guidance during orthopedic surgical procedures by using patient CT data to assist a surgeon with pre-surgical planning, implant placement and interpretive/intraoperative navigation of the patient's anatomy.

The Mako robotic arm, once configured for a specific application, can serve as surgeon's "intelligent" tool holder or tool guide by passively constraining the preparation of an anatomical site for an orthopedic implant with software-defined spatial boundaries.

Summary of Technological Characteristics Compared to Predicate Devices: The technological characteristics of the Mako Total Knee Application compared to the predicate device are listed below:

| Technological<br>Characteristics | Mako Total Knee Application | Mako Total Knee Application<br>(K143752) |
|----------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Major<br>Components | Guidance Module, robotic arm,<br>camera stand, cutting system,<br>preoperative planning laptop. | Guidance Module, robotic arm,<br>camera stand, cutting system,<br>preoperative planning laptop. |
| Tools/accessories | Various reusable and disposable<br>instruments | Various reusable and disposable<br>instruments |
| Image Use | CT | CT |

## Intended Use/Indications for Use:

The Mako System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Mako System 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 relative to a CT based model of the anatomy. These procedures include:

- . Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:

- . Triathlon Total Knee System (CR/CS/PS cemented Primary)
- Kinetis Total Knee System (CR/UC)

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## Performance Data:

| Validation / Verification<br>Method | Purpose | Validation / Verification<br>Results |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Product Specification<br>Verification | Verify that TKA fields and<br>values implemented into<br>the eRequest application<br>must match the TKA<br>Product Specifications. | Pass |
| eRequest – Full System<br>Run Through for TKA<br>Application | Verify the integration of<br>the eRequest Lifecycle<br>into the Mako System<br>provides adequate<br>functionality to<br>successfully complete the<br>pre-operative planning<br>workflow | Pass |
| Planning Workflow - TKA<br>Validation | Validate in a simulated-<br>use environment, with<br>appropriate user, that the<br>implementation of<br>eRequest LifeCycle into<br>the Mako System provides<br>adequate functionality to<br>successfully complete the<br>pre-operative workflow<br>and satisfies the customer<br>requirements. | Pass |

## Conclusions of Performance Testing:

Performance testing has demonstrated that the characteristics of the Mako Total Knee Application are equivalent to the predicate device, and that the device is as safe and as effective as the predicate device and does not raise different questions of safety and effectiveness, and therefore, supports a determination of Substantial Equivalence.

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