MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM

K141989 · Mako Surgical Corporation · OLO · Nov 13, 2014 · Neurology

Device Facts

• Record ID: K141989
• Device Name: MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
• Applicant: Mako Surgical Corporation
• Product Code: OLO · Neurology
• Decision Date: Nov 13, 2014
• 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. It utilizes patient CT data for pre-operative planning and intraoperative navigation. The system includes an optical detector, robotic arm, guidance module, and planning laptop. During surgery, the robotic arm acts as an intelligent tool guide, providing passive constraint via software-defined spatial boundaries to assist the surgeon in preparing anatomical sites for implants. The system supports orthopedic procedures by providing spatial orientation and reference information. Modifications in this version include the MAKO Integrated Cutting System (MICS), inline offset cup impactor, MICS endcap, reamer attachment, 4.0mm bone pins, RIO Base Array, and updated reduction results for hip length and combined offset. The device is used in clinical settings by surgeons to improve surgical precision and implant placement.

Clinical Evidence

Bench testing only. Performance evaluation included RIO arm and MICS communication tests, MICS handpiece and cover functional tests, inline offset cup impactor thread connection tests, reamer attachment tests, RIO base array functional tests, THA application performance tests, and full system integration tests. No clinical data was required or presented.

Technological Characteristics

System comprises a robotic arm, optical detector (camera stand), guidance module, and preoperative planning laptop. Utilizes patient CT data for navigation. Employs software-defined spatial boundaries for passive constraint of surgical tools. Includes specialized instrumentation (MICS, reamer attachments, bone pins). Connectivity via integrated system architecture. Sterilization requirements for reusable instruments apply.

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 RIO - Total Hip Arthroplasty (K121064)

Submission Summary (Full Text)

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

November 13, 2014

Mako Surgical Corporation Mr. Jonathan Reeves Principal Regulatory Specialist 2555 Davie Road Fort Lauderdale, Florida 33317

Re: K141989

Trade/Device Name: MAKOplasty Total Hip Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: October 8, 2014 Received: October 14, 2014

Dear Mr. Reeves:

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

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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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.

# 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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Image /page/2/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features a stylized blue arc above the word "MAKO" in bold, black letters. Below "MAKO" is the text "SURGICAL CORP." in a smaller, less bold font, also in black. The logo is clean and modern, with the blue arc providing a visual element that suggests movement or technology.

555 Davie Road • Ft. Lauderdale, FL 2044 • Fax [phone] ww.makosurgical.com

# INDICATIONS FOR USE

510(k) Number: K141989

Device Name: Total Hip Application (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 O
- o Total hip arthroplasty (THA)

Prescription Use

OR

Over-the-Counter Use

(Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image is a logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, black letters. Below the word "MAKO" is the phrase "SURGICAL CORP." in smaller, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or an abstract mountain range.

1555 Davie Road • Ft. Lauderdale, FL 33317 hone 954.927.2044 • Fax [phone] ww.makosurgical.com

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 Jonathan Reeves July 03, 2014 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 K121064.

## Device Modifications:

- MAKO Integrated Cutting System (MICS)
- Inline offset cup impactor ●
- MICS endcap
- . Reamer attachment
- 4.0mm bone pins
- RIO Base Array
- Reduction Results: hip length and combined offset

Device Description: MAKOplasty Total Hip Application is an upgrade to RIO-THA (K121064). 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, cutting system, and a robotic arm. The system's architecture is designed to support two main surgical applications: total hip procedures and partial knee procedures. With application specific hardware and software, it provides stereotactic guidance during minimally invasive orthopedic surgical

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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.

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>(K121064) | |
|----------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------|
| Major<br>Components | Guidance Module, robotic arm, camera stand, cutting system, preoperative planning laptop. | Guidance Module, robotic arm, camera stand, cutting system, preoperative planning laptop. | |
| | Tools/accessories | Various reusable instruments | Various reusable instruments |
| | Images Use | CT | CT |

## 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 ●
- Total hip arthroplasty (THA) .

#### Performance Data:

The Robotic Arm Interactive Orthopedic System (RIO) has been evaluated through nonclinical performance testing for:

- RIO arm and MICS communication Test ●
- MICS Handpiece Functional Test ●
- MICS Cover Functional Test
- Inline Offset Cup Impactor Thread Connection Functional Test
- MICS Reamer Attachment Functional Test
- RIO Base Array Functional Test ●
- THA Application Performance Test ●
- Full System Test ●

#### Conclusions of Non-clinical Data:

The results of testing indicated the device performed within the intended use and

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did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices.

### Summary of Design Control Activities:

The risk analysis activities for this device modification include a risk management plan, hazard analysis and Failure Modes and Effects Analysis (FMEAs). Based upon the review of this data and information obtained through verification and validation activities, there are no unacceptable levels of risks that have been identified resulting from the device modification.