MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP

K083644 · Mako Surgical Corp. · OLO · Jun 19, 2009 · Neurology

Device Facts

• Record ID: K083644
• Device Name: MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
• Applicant: Mako Surgical Corp.
• Product Code: OLO · Neurology
• Decision Date: Jun 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The Tactile Guidance System - Hip is indicated for use in surgical 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: Acetabular reaming during total hip arthoplasty (THA)

Device Story

TGS-Hip is a stereotaxic instrument for orthopedic surgery; assists surgeons in acetabular reaming during total hip arthroplasty. System inputs: patient CT data for presurgical planning and real-time optical tracking of surgical tools. Operation: robotic arm acts as an 'intelligent' tool holder/guide; arm is passively constrained by software-defined spatial boundaries. Surgeon uses system in OR to guide standard surgical tools (burrs, reamers) relative to anatomy. Output: visual navigation and physical haptic guidance (via robotic arm constraints) to ensure precise implant site preparation. Benefits: improved accuracy in bone preparation through stereotactic guidance and boundary enforcement.

Clinical Evidence

No clinical data. Evidence consists of bench testing using sawbone models to evaluate setup, registration, accuracy, and functionality during acetabular reaming. Further validation performed using cadaveric material with postoperative x-ray/CT scan evaluation to confirm system accuracy and intended use performance.

Technological Characteristics

System includes optical detector, computer, robotic arm, and dedicated instrumentation. Uses CT-based imaging for navigation. Robotic arm is electromechanical, providing passive haptic constraints via software-defined spatial boundaries. Connectivity involves tracking of probes/arrays via optical camera. Sterilization and specific material standards not detailed.

Indications for Use

Indicated for surgical hip procedures, specifically acetabular reaming during total hip arthroplasty (THA), where stereotactic surgery is appropriate and rigid anatomical bony structures can be identified relative to a patient-specific CT 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

• Tactile Guidance System (K072806)
• Brainlab Vectorvision Hip (K010602, K040368, K052213, K072716)
• Orthosoft Navitrack System - Total Hip Replacement (K022364)

Submission Summary (Full Text)

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083644

JUN 19 2009

fort lauderdale_florida 33317 fəx 954.927 0446 tel 954,927 2044 2555 davie road

# EXHIBIT 9 510(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 December 5, 2008 Tactile Guidance System - Hip (TGS - Hip) 21 CFR 882.4560 Stereotaxic Instrument Class II HAW

Substantial Equivalence Claimed To: The TGS – Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System (K072806), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364).

Description: The TGS - Hip is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. The TGS – Hip is enabled for use in conjunction with a 30 party drill system (e.g., Stryker drill system) in order to support the surgeon's preparation of the acetabulum during total hip arthroplasty. The TGS – Hip uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The TGS - Hip robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS - Hip robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as burrs and reamers.

### Summary of Technological Characteristics Compared to Predicate Devices:

The technological characteristics of the TGS-Hip compared to the predicate devices is listed below.

| Technological Characteristics | TGS-Hip | Brainlab Vectorvision (VV)<br>Hip | Orthosoft Navitrack<br>System - Total Hip<br>Replacement |
|-------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------|
| Major Components | Guidance Module, robotic<br>arm, camera stand | Available in several different<br>configurations (VV-Compact,<br>VV-Sky, VV-2) | Computer cart, camera<br>stand |
| Tools/accessories | Various probes, arrays tracked<br>by optical camera | Various probes, arrays<br>tracked by optical camera | Various probes, arrays<br>tracked by optical camera |
| Images Use | CT | CT, CT-free | CT |

## Performance Data:

System level verification testing was performed in the laboratory with TGS-Hip using sawbone models to evaluate setup, registration, and overall accuracy and functionality of the system in supporting acetabular reaming during THA. Further testing was performed with TGS-Hip using cadaveric material where postoperative x-rays/CT scans 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 TGS-Hip to the predicate devices.

Intended Use/Indications for Use: The Tactile Guidance System - Hip is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical

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K0Y3644

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255 davie road

2555 davie road

fax [phone]

structures during orthopedic procedures. The Tactile Guidance System - Hip is indicated for use in Stravaros dailing of thopours procedures. In the reserv 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:

Acetabular reaming during total hip arthoplasty (THA) ்

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

Public Health Service

JUN 19 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083644

Trade/Device Name: Tactile Guidance System - Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: May 28, 2009 Received: June 2, 2009

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. William F. Tapia

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/cdrh/mdr/ 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 1 http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Per

Per

Per D.N

Per

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

Enclosure

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683644

Image /page/4/Picture/1 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 graphic that resembles a shark fin or a mountain peak. The logo is simple and modern, and it conveys a sense of strength and precision.

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

#### INDICATIONS FOR USE

510(k) Number (if known): K083644

Device Name: Tactile Guidance System - Hip

Indications for Use:

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

The Tactile Guidance System - Hip is indicated for use in surgical 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: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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)

Nil keogh for mxm
(Division Sign Off)

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083644