Partial Knee Application (PKA)

K142530 · Mako Surgical Corporation · OLO · Sep 16, 2015 · Neurology

Device Facts

• Record ID: K142530
• Device Name: Partial Knee Application (PKA)
• Applicant: Mako Surgical Corporation
• Product Code: OLO · Neurology
• Decision Date: Sep 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee 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. The Implant systems with which the system is compatible: - Restoris Multicompartmental Knee System - Restoris Porous Partial Knee System

Device Story

The Partial Knee Application (PKA) is an upgrade to the RIO robotic surgical system. It utilizes patient CT data to assist surgeons in pre-operative planning and intraoperative navigation for partial knee arthroplasty. The system includes an optical detector, robotic arm, guidance module, and a pre-operative planning laptop. During surgery, the robotic arm acts as an intelligent tool guide, passively constraining bone preparation to software-defined spatial boundaries based on the CT model. New features include the MAKO Integrated Cutting System (MICS) with associated accessories, a bone mineral density (BMD) phantom for density assessment, and motorized tool alignment. The system is operated by a surgeon in an OR setting. By providing real-time stereotactic guidance and haptic constraints, the device aims to improve the accuracy of bone resection and implant placement, potentially benefiting patients through more precise surgical outcomes.

Clinical Evidence

Bench testing only. Validation included functional testing of the MICS handpiece and attachments, base array assemblies, bone arrays, and clamps. System-level testing verified PKA application performance, bone mineral density functionality, and overall system accuracy (bone registration and resection). Simulated-use validation confirmed the integration of the RIO system with the Restoris Multicompartmental and Restoris Porous implant systems.

Technological Characteristics

System components: Guidance module, robotic arm, optical camera stand, cutting system (MICS), and pre-operative planning laptop. Inputs: Patient CT data. Sensing: Optical tracking of rigid anatomical structures. Actuation: Robotic arm providing passive haptic constraints. Connectivity: Networked/integrated system components. Software: Application-specific guidance software for stereotactic navigation.

Indications for Use

Indicated for surgical knee procedures, including unicondylar and patellofemoral knee replacement, where stereotactic surgery is appropriate and rigid anatomical bony structures can be identified relative 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 – PKA (Partial Knee Application) (K112507)
• RIO - TKA (Total Knee Application) (K143752)

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

September 16, 2015

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

Re: K142530

Trade/Device Name: Partial Knee Application (PKA) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 8, 2015 Received: August 10, 2015

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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Page 2 - Mr. Jonathan Reeves

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K142530

Device Name Partial Knee Application (PKA)

#### Indications for Use (Describe)

The Partial Knee Application (PK A), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee 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.

The Implant systems with which the system is compatible:

- · Restoris Multicompartmental Knee System
- · Restoris Porous Partial Knee System

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

555 Davie Road • Ft. Lauderdale, FL one 954.927.2044 • Fax [phone] ww.makosurgical.com

510(K) SUMMARY

| Submitter: | MAKO Surgical Corp. |
|------------------------|--------------------------------------------|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number: | 954-628-0655 |
| Fax number: | 954-927-0446 |
| Contact Person: | Jonathan Reeves |
| Date Prepared: | Aug 29, 2014 |
| Device Trade Name: | Partial Knee Application (PKA) |
| Regulation Name: | Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Device Classification: | Class II |
| Product Code: | OLO |

### Primary Predicate Device:

Partial Knee Application is substantially equivalent to the following 510(k) cleared device:

| Device Name | Manufacturer | 510(k) # |
|--------------------------------------|---------------|----------|
| RIO – PKA (Partial Knee Application) | MAKO Surgical | K112507 |

### Additional Predicate Devices:

| Device Name | Manufacturer | 510(k) # |
|------------------------------------|---------------|----------|
| RIO - TKA (Total Knee Application) | MAKO Surgical | K143752 |

Device Modifications: The following modifications have been made to RIO Partial Knee Application:

- A power tool to perform the cutting for partial knee arthroplasty (MAKO ● Integrated Cutting System (MICS)) has been added to the system.
- Accessories (drills, burrs, blades and attachments) for the MICS cutting system have been added to the system
- A bone mineral density (BMD) phantom has been added to the system which ● allows the system to display the CT scan on a density scale in standard units. The BMD feature is intended to provide the surgeon with a means to assess bone density.
- . Instrumentation (arrays, bone pins, gap spoons) have been modified or added to the system to improve the usability of the system
- . The ability to implant the Restoris Porous implant system using the RIO system was added to the system.
- . Motorized tool alignment for the RIO setup has been added to the system to improve ease of use.

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- Range of motion increase on RIO to improve ease of use. ●
Description: Partial Knee Application is an upgrade to RIO-PKA (K112507). The features of this application are to improve overall performance of the system in supporting partial knee arthroplasty. Partial Knee 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 partial knee procedures. 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.

| Summary of Technological Characteristics Compared to Predicate Devices: The | |
|-------------------------------------------------------------------------------------|--|
| technological characteristics of Partial Knee Application compared to the predicate | |
| device are listed below: | |

| Technological<br>Characteristics | Partial Knee<br>Application | RIO-PKA<br>(K112507) | RIO-TKA<br>(K143752) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Major<br>Components | Guidance<br>Module, robotic<br>arm, camera<br>stand, cutting<br>system,<br>preoperative<br>planning laptop. | Guidance Module,<br>robotic arm, camera<br>stand, cutting system,<br>preoperative planning<br>laptop. | Guidance Module,<br>robotic arm, camera<br>stand, cutting<br>system,<br>preoperative<br>planning laptop. |
| Tools/accessori<br>es | Various reusable<br>instruments | Various reusable<br>instruments | Various reusable<br>instruments |
| Images Use | CT | CT | CT |

### Intended Use/Indications for Use

The Partial Knee Application (PKA), for use with 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 Partial Knee Application (PKA), for use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures, in which the

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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.

The Implant systems with which the system is compatible:

- Restoris Multicompartmental Knee System .
- Restoris Porous Partial Knee System ●

### Performance Data:

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

| Validation / Verification | Acceptance Criteria | Validation / Verification |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Method | | Results |
| MICS Handpiece<br>Functional Test | This verification test is<br>intended to verify the<br>MAKO Integrated Cutting<br>System (MICS)<br>requirements. | Pass |
| MICS Attachments<br>Functional Test | This verification test is<br>intended to verify that the<br>straight sagittal saw blades<br>met applicable<br>specifications. | Pass |
| RIO Base Array Functional<br>Test | This verification test is<br>intended to verify that the<br>Base Array assemblies<br>when used with the Base<br>Array Connector meet<br>applicable specifications. | Pass |
| Bone Arrays and Clamps<br>Functional Test | This verification test is<br>intended to verify that the<br>array movement is equal or<br>less than the assembly<br>requirement to a fixed<br>position after cutting. | Pass |
| PKA Application<br>Performance Test | This verification test is<br>intended to verify that the<br>real time performance of the<br>PKA application met<br>applicable specifications. | Pass |
| Disposable Cutter Strength<br>Testing | This verification test is<br>intended to verify that the<br>narrow saw blades met | Pass |
| | applicable specifications. | |
| Bone Mineral Density<br>Application Functional Test | This verification test is<br>intended to verify that the<br>Bone Mineral Density<br>function met applicable<br>specifications. | Pass |
| Full System Run-through<br>test | This verification test is<br>intended to verify that the<br>Partial Knee Application<br>Software, and supporting<br>instrumentation provides<br>adequate functionality to be<br>able to successfully<br>complete a PKA | Pass |
| System Accuracy Test | The purpose of this test is to<br>determine the overall<br>system accuracy as a result<br>of bone registration and<br>bone resection accuracy.<br>This protocol will use the<br>verification results obtained<br>from bone registration<br>verification test and bone<br>resection test and combine<br>these results using a<br>statistical approach. | Pass |
| PKA System Validation<br>with MCK Implant system | Validate in a simulated-use<br>environment that the<br>integration of the Robotic<br>Arm Interactive Orthopedic<br>System (RIO) with the<br>Partial Knee Application<br>Software, MCK implant<br>system and supporting<br>instrumentation provides<br>adequate functionality to<br>successfully complete a<br>Partial Knee Arthroplasty<br>procedure and satisfies the<br>customer requirements. | Pass |
| PKA System Validation<br>with Restoris Porous<br>Implant system | Validate in a simulated-use<br>environment that the<br>integration of the Robotic<br>Arm Interactive Orthopedic<br>System (RIO) with the | Pass |
| Partial Knee Application | | |
| Software, Restoris implant | | |
| system and supporting | | |
| instrumentation provides | | |
| adequate functionality to | | |
| successfully complete a | | |
| Partial Knee Arthroplasty | | |
| procedure and satisfies the | | |
| customer requirements. | | |

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## Conclusions of Non-clinical Data:

The results of testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate device.

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