MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM

K121064 · Mako Surgical Corporation · OLO · Jun 6, 2012 · Neurology

Device Facts

• Record ID: K121064
• Device Name: MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
• Applicant: Mako Surgical Corporation
• Product Code: OLO · Neurology
• Decision Date: Jun 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip 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: Unicondylar knee replacement and/or patellofemoral knee replacement; Total hip arthroplasty (THA).

Device Story

MAKOplasty Total Hip Application is an upgrade to the RIO-THA system; provides stereotactic guidance for orthopedic surgery. System inputs include patient CT data for pre-operative planning. The RIO platform comprises an optical detector, computer, robotic arm, and guidance module. During surgery, the system uses the CT-based model to provide intraoperative navigation; the robotic arm acts as an 'intelligent' tool holder or guide, passively constraining surgical tools within software-defined spatial boundaries to assist the surgeon in anatomical site preparation. Used in clinical settings by surgeons; output is visual navigation and physical haptic guidance. Benefits include improved precision in implant placement and anatomical preparation through software-defined boundaries.

Clinical Evidence

Bench testing only. Verification testing included partial knee application verification, system accuracy, and full application software runthrough. Validation testing included a total hip application full cadaver validation lab. All testing passed.

Technological Characteristics

System includes robotic arm, optical detector, guidance module, and preoperative planning laptop. Uses CT imaging for anatomical modeling. Provides stereotactic guidance via software-defined spatial boundaries. Operates as a tool guide/holder. Connectivity includes preoperative planning workstation. Software supports dual-application (hip and knee) installation.

Indications for Use

Indicated for patients undergoing surgical knee (unicondylar or patellofemoral) or hip (total hip arthroplasty) procedures 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 Surgical Robotic Arm Interactive Orthopedic System (RIO) - Total Hip Arthroplasty (THA) (K093425)

Reference Devices

• RIO (K112507)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font size underneath. Above the word "MAKO" is a stylized graphic element that resembles an arrow or a stylized letter "A". At the top of the image is the number "K121064".

t lauderdale, florida 33317

JUN - 6 2012 page i of 2

2555 davie road

tal 954,927

fax [phone]

### 510(K) SUMMARY

Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Device Trade Name: Regulation Name: Regulation Number: Device Classification: Product Code:

MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL 33317 954-628-0655 954-927-0446 Dionne Sanders April 4, 2012 MAKOplasty Total Hip Application . Stereotaxic Instrument 21 CFR 882.4560 Class II OLO

Substantial Equivalence Claimed To: MAKOplasty Total Hip Application is substantially equivalent to MAKO Surgical's (Robotic Arm Interactive Orthopedic System) RIO - (Total Hip Arthroplasty) THA cleared via K093425.

Description: MAKOplasty Total Hip Application is an upgrade to RIO-THA (K093425). The features of this application are to improve overall performance of the system in supporting total hip arthroplasty. MAKOplasty Total Hip Application is used with RIO which includes an optical detector, robotic arm, and guidance module. In addition, the application is designed to be used with a pre-operative planning laptop, as well as both reusable and disposable instrumentation.

The main RIO platform includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, drill system, and a robotic arm. The system's architecture is designed to support two main surgical applications: hip procedures and knee procedures (per K112507). With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical procedures by using patient CT data to assist a surgeon with presurgical planning and interpretive/intraoperative navigation.

RIO's 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.

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Image /page/1/Picture/0 description: This image contains the logo for MAKO Surgical Corp. The image also contains the text 'K121064' at the top, and 'Page 7 of 2' on the right side. At the bottom of the image, the address '2555 davie road fort lauderdale, florida 33317' is printed, along with the phone number 'tel [phone]' and fax number 'fax [phone]'.

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

| Technological<br>Characteristics | MAKOplasty Total Hip<br>Application | RIO-THA<br>(K093425) |
|----------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Major<br>Components | Guidance Module, robotic arm, camera stand, drill system, preoperative planning laptop. | Guidance Module, robotic arm, camera stand, drill system, preoperative planning laptop. |
| Tools/accessories | Various reusable instruments | Various reusable instruments |
| Images Use | CT | CT |

Performance Data: Unit, Integration and System level testing was performed with the MAKOplasty Total Hip Application with the knee software dually installed in order to evaluate the application's ability to support total hip arthroplasty procedures, and unicondylar and/or patellofemoral knee replacement. A summary of the completed design verification and validation activities to support substantial equivalence is as follows:

Verification Testing - All testing Passed

- Partial Knee Application Verification ●
- . System Accuracy
- Full Application Software Runthrough .

Validation Testing- Passed

- . Total Hip Application Full Cadaver Validation Lab
## Intended Use/Indications for Use

The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The RIO is indicated for use in surgical knee and hip 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:

- Unicondylar knee replacement and/or patellofemoral knee replacement o
- Total hip arthroplasty (THA) 0

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure with three arms or lines extending upwards, symbolizing health, services, and humanity. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

#### Public Health Service

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

JUN - 6 2012

Mako Surgical Corporation c/o Ms. Dionne Sanders Senior Regulatory Affairs Specialist 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K121064

Trade/Device Name: Makoplasty Total Hip Application, RIO Standard System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 8, 2012 Received: May 11, 2012

Dear Ms. Dionne Sanders:

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 10 too barranor 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.

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Page 2 - Ms. Sanders

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

for

Nop

OL

Mark N. Melk rson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the logo is a black graphic that resembles an abstract shape. At the top of the image, there is a handwritten text "K121064".

fort lauderdale, florida 33317

tel [phone]

fax [phone]

### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: MAKOplasty Total Hip Application

Indications for Use:

The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical'structures during orthopedic procedures.

The RIO is indicated for use in surgical knee and hip 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:

Unicondylar knee replacement and/or patellofemoral knee replacement ಂ

. Total hip arthroplasty (THA) o

Prescription Use X OR

Over-the-Counter Use

(Per 21 CFR 801.109)

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121064