MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

K093425 · Mako Surgical Corp. · OLO · Feb 24, 2010 · Neurology

Device Facts

• Record ID: K093425
• Device Name: MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
• Applicant: Mako Surgical Corp.
• Product Code: OLO · Neurology
• Decision Date: Feb 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

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

RIO-THA is a robotic-assisted stereotaxic surgical system used in orthopedic procedures. Input consists of patient CT scan data for preoperative planning and intraoperative navigation. The system utilizes an optical detector, computer, and robotic arm to provide stereotactic guidance. During surgery, the system registers rigid anatomical bony structures to the CT model; the robotic arm acts as an 'intelligent' tool holder or guide, providing passive constraint of surgical tools via software-defined spatial boundaries. Used in clinical settings by surgeons, the system assists in the preparation of anatomical sites for implants. Benefits include enhanced precision and orientation during minimally invasive procedures. Output is visual navigation and physical haptic guidance for the surgeon.

Clinical Evidence

Bench testing only. System-level verification performed using sawbone models to evaluate setup, registration, accuracy, and functionality. Validation performed using cadaveric material with post-operative x-ray evaluation to confirm intended use and performance criteria.

Technological Characteristics

System includes optical detector, computer, robotic arm, drill system, and tracked probes/arrays. Uses CT-based image guidance. Robotic arm provides passive haptic constraint via software-defined spatial boundaries. Connectivity via integrated computer platform. Sterilization of tools/accessories required.

Indications for Use

Indicated for patients undergoing unicondylar knee replacement, patellofemoral knee replacement, or total hip arthroplasty (THA) 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

• RIO-Hip (K091998)
• Tactile Guidance System v2.0 (a.k.a. RIO, K081867)
• Brainlab Vectorvision Hip (K010602, K040368, K052213, K072716)
• Orthosoft Navitrack System – Total Hip Replacement (K022364)
• Stryker Navigation System-CT Based Hip Module (K050615)
• Stryker Navigation System-Hip Module (K022365)

Submission Summary (Full Text)

{0}------------------------------------------------

FEB 2 4 2010

Image /page/0/Picture/1 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 abstract shape. At the top of the image, the text "K093425" is written in handwriting.

Page 1 of 2

2555 davie road fort lauderdale, florida 33317 tel [phone]

fax 954.927.044

# EXHIBIT 2 510(K) SUMMARY

| Submitter: |
|--------------------|
| Address: |
| Phone number: |
| Fax number: |
| Contact Person: |
| Date Prepared: |
| Device Trade Name: |
| Regulation Number: |
| Regulation Name: |
| Regulatory Class: |
| Product Code: |

MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL. 33317 954-927-2044 x 605 954-927-0446 William F. Tapia November 1, 2009 Robotic Arm Interactive Orthopedic System - THA (RIO - THA) 21 CFR 882.4560 Stereotaxic Instrument Class II OLO

Substantial Equivalence Claimed To: RIO - THA is substantially equivalent to MAKO Surgical's RIO -Hip (K091998), Tactile Guidance System v2.0 (a.k.a. RIO, K081867), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716), Orthosoft's Navitrack System – Total Hip Replacement (K022364), Stryker's Navigation System-CT Based Hip Module (K050615) and Stryker's Navigation System-Hip Module (K022365).

Description: 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: knee procedures (per the predicate device K081867) and THA procedures (per RIO-THA described in this 510(k) submission). 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 (knee or hip), 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 RIO-THA compared to the predicate devices are listed below:

| Technological<br>Characteristics | RIO-THA | RIO (K081867), RIO-Hip<br>(K091998) | Brainlab Vectorvision (VV)<br>(K010602, K040368,<br>K052213, K072716) | Orthosoft Navitrack System –<br>Total Hip Replacement<br>(K022364) | Stryker Navigation<br>System-Hip Module<br>(K050615, K022365) |
|----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------------------------------------------|
| Major<br>Components | Guidance Module,<br>robotic arm, camera<br>stand, drill system | Guidance Module, robotic<br>arm, camera stand, drill<br>system | Available in several different<br>configurations (VV-Compact,<br>VV-Sky, VV-2) | Computer cart, camera stand | Computer cart,<br>camera stand |
| Tools/accessories | Various probes, arrays<br>tracked by optical<br>camera | Various probes, arrays<br>tracked by optical camera | Various probes, arrays tracked<br>by optical camera | Various probes, arrays tracked<br>by optical camera | Various probes, arrays<br>tracked by optical<br>camera |
| Images Use | CT | CT | CT, CT-free | CT | CT |

## Performance Data:

System level verification testing was performed in the laboratory with RIO-THA using sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting THA. Further testing was performed with RIO-THA using cadaveric material where post-operative x-rays were obtained and evaluated in order to validate the system's intended use. The results of these tests satisfied all required acceptance criteria and were found to support substantial equivalence of the RIO-THA to the predicate devices.

{1}------------------------------------------------

Image /page/1/Picture/0 description: This image contains the logo for MAKO Surgical Corp, along with the text 'K093425' and 'Page 2 of 2'. The image also contains the address '2555 davie road fort lauderdale, florida 33317' and the phone and fax numbers 'tel [phone]' and 'fax [phone]' respectively. The logo is a stylized 'MAKO' with the words 'SURGICAL CORP.' underneath.

## 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 r no no 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) o

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around the perimeter. In the center is a stylized image of a bird-like figure, possibly representing an eagle, with its wings spread.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

# FEB 2 4 2010

Mako Surgical Corp. % Mr. William F. Tapia Director, Regulatory Affairs 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K093425

Trade/Device Name: Robotic Arm Interactive System - THA Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2010 Received: January 25, 2010

Dear Mr. Tapia:

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

{3}------------------------------------------------

Page 2 - Mr. William F. Tapia

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

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 word MAKO is a stylized arrow pointing upwards. At the top of the image is the text "Co 93425".

2555 davie road fort lauderdale, florida 33317 tel [phone]

fax [phone]

### EXHIBIT 1

### INDICATIONS FOR USE

510(k) Number (if known): K093425

Device Name: RIO-THA

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 0
- Total hip arthroplasty (THA) 0

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × 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)

Peter Thoms

(Division Sign-Off) Division of Survical, Orthopedic, and Restorative Devices

510(k) Number /093428