ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP

K091998 · Mako Surgical Corp. · OLO · Sep 28, 2009 · Neurology

Device Facts

• Record ID: K091998
• Device Name: ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
• Applicant: Mako Surgical Corp.
• Product Code: OLO · Neurology
• Decision Date: Sep 28, 2009
• Decision: SESE
• Submission Type: Traditional
• 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 o - Acetabular reaming during total hip arthoplasty (THA) o

Device Story

RIO-Hip is a stereotaxic surgical system assisting orthopedic surgeons during minimally invasive procedures. Input consists of patient CT data for presurgical planning and intraoperative navigation via an optical detector. The system includes a computer, drill system, and robotic arm. During surgery, the system tracks probes and arrays using an optical camera to register anatomy. The robotic arm acts as an 'intelligent' tool holder or guide, providing passive constraint of surgical tools within software-defined spatial boundaries. This assists the surgeon in acetabular reaming during THA and knee replacements. The system provides real-time navigation and haptic-like guidance, helping ensure accurate implant placement relative to the patient's specific anatomy. Used in clinical settings by surgeons.

Clinical Evidence

No clinical trials performed. Evidence consists of bench testing and cadaveric studies. Laboratory verification used sawbone models to evaluate setup, registration, and accuracy of acetabular reaming. Cadaveric material was used to validate intended use, with postoperative x-rays evaluated to confirm accuracy. Results satisfied all acceptance criteria.

Technological Characteristics

System includes guidance module, robotic arm, optical camera stand, and drill system. Utilizes CT-based anatomical modeling. Employs optical tracking of probes and arrays. Software provides spatial boundary definition for tool guidance. Connectivity via integrated computer platform. Sterilization of surgical tools required.

Indications for Use

Indicated for patients undergoing surgical knee or hip procedures where stereotactic surgery is appropriate and rigid anatomical bony structures can be identified relative to a CT-based model. Specific procedures include unicondylar knee replacement, patellofemoral knee replacement, and acetabular reaming during total hip arthroplasty (THA).

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 - Hip (K083644)
• Tactile Guidance System v2.0 (K081867)
• Brainlab Vectorvision Hip (K010602, K040368, K052213, K072716)
• Orthosoft Navitrack System - Total Hip Replacement (K022364)

Submission Summary (Full Text)

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lori lauderdale, flonda 33317 2555 davie road tel [phone] fax [phone]_

### 510(K) SUMMARY

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

MAKO Surgical Corp. 2555 Davie Road, Fort Lauderdale, FL, 33317 954-927-2044 x 605 954-927-0446 William F. Tapia June 30, 2009 Robotic Arm Interactive Orthopedic System - Hip (RIO - Hip) 21 CFR 882.4560 Stereotaxic Instrument Class II OLO

Substantial Equivalence Claimed To: RIO – Hip is substantially equivalent to MAKO Surgical's Tactile Guidance System - Hip (K083644), Tactile Guidance System v2.0 (K081867), Brainlab's Vectorvision Hip (K010602, K040368, K052213, K072716) and Orthosoft's Navitrack System - Total Hip Replacement (K022364).

Description: The main 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 hip procedures (per RIO-Hip 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. The 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-Hip compared to the predicate devices are listed below:

| Technological<br>Characteristics | RIO-Hip | Tactile Guidance System<br>(K083644, K081867) | Brainlab Vectorvision<br>(VV)<br>(K010602, K040368,<br>K052213, K072716) | Orthosoft Navitrack<br>System - Total Hip<br>Replacement<br>(K022364) |
|----------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Major Components | Guidance Module,<br>robotic arm, camera<br>stand, drill system | Guidance Module, robotic<br>arm, camera stand, drill<br>system | Available in several<br>different configurations<br>(VV-Compact, VV-Sky,<br>VV-2) | 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<br>tracked by optical camera | Various probes, arrays<br>tracked by optical<br>camera |
| Images Use | CT | CT | CT, CT-free | CT |

#### Performance Data:

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

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| 2555 Davie Road | Fort Lauderdale, Florida 33317 | tel: [phone] | fax: [phone] |
|-----------------|--------------------------------|-------------------|-------------------|
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#### 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
- Acetabular reaming during total hip arthoplasty (THA) o

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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.

SEP 28 2009

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

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

Re: K091998

Trade/Device Name: RIO-Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: September 2, 2009 Received: September 3, 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. Iisting 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 Eederal Regulations Title 21 Barts 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/ucm111800 html 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 Port 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/cdrl/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 tolling the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millhiser

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

Enclosure

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Kc. 9 1998

2555 davie road fort lauderdale, florida 33317 lel 954.927.2044 fax [phone]

## EXHIBIT 1

#### INDICATIONS FOR USE

510(k) Number (if known): K091998

Device Name: RIO-Hip

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 an probedures can be identified relative to a CT based model of the anatomy. These procedures include:

- Unicondylar knee replacement and/or patellofemoral knee replacement o
- 0 Acetabular reaming during total hip arthoplasty (THA)

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. Graham
(Division Sign Off)

ion of Surgical, Orthopedic, Restorative Device

510(k) Number K091998