RESTORIS Multicompartmental Knee System

K150307 · Mako Surgical Corp. · NPJ · Mar 10, 2015 · Orthopedic

Device Facts

• Record ID: K150307
• Device Name: RESTORIS Multicompartmental Knee System
• Applicant: Mako Surgical Corp.
• Product Code: NPJ · Orthopedic
• Decision Date: Mar 10, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Restoris™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: - Medial unicondylar - Lateral unicondylar - Patellofemoral - Medial bi-compartmental (medial unicondylar and patellofemoral) The RESTORIS™ Multicompartmental Knee System is for single use only and is intended for implantation with bone cement.

Device Story

Implant system for single or multi-compartmental knee replacement; used in conjunction with RIO® Robotic Arm Interactive Orthopedic System. Components include femoral condyle, tibial onlay/inlay, patellofemoral trochlear, and patella implants. Designed for implantation with bone cement. Modification adds highly cross-linked UHMWPE (X3) tibial inserts, gas plasma sterilization, and updated packaging. System treats osteoarthritis or posttraumatic arthritis; components designed with 3mm gap to prevent interference during multi-compartmental procedures. Intended for use by orthopedic surgeons in clinical settings.

Clinical Evidence

Bench testing only. Evaluations included insert snaplock strength, tibial insert/baseplate micromotion, tibio-femoral range of motion, instability, contact area and stress, tibial insert fatigue, tibial insert wear, packaging validation, gas plasma sterilization validation, and 5-year aging studies.

Technological Characteristics

Implant system composed of metal and polymer components. Features highly cross-linked UHMWPE (X3) tibial inserts. Designed for cemented implantation. Sterilization via gas plasma. System is used with RIO® robotic platform for surgical guidance.

Indications for Use

Indicated for individuals with osteoarthritis or posttraumatic arthritis of tibiofemoral and/or patellofemoral articular surfaces requiring single or multi-compartmental knee replacement. Configurations include medial/lateral unicondylar, patellofemoral, and medial bi-compartmental. For use with RIO® Robotic Arm Interactive Orthopedic System.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• RESTORIS Multicompartmental Knee System (K133039)

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

March 10, 2015

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

Re: K150307

Trade/Device Name: RESTORIS™ Multicompartmental Knee (MCK) System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: NPJ, HSX, HRY, KRR, OIY Dated: January 29, 2015 Received: February 9, 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

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Page 2 - Mr. Jonathan Reeves

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

# Lori A. Wiggins -S

for

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

Enclosure

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# Indications for Use

510(k) Number (if known) K150307

Device Name

RESTORISTM Multicompartmental Knee (MCK) System

Indications for Use (Describe)

RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

- Medial unicondylar
- Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)

RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

X 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 is a 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, thinner, black letters. Above the word "MAKO" is a blue, curved shape that resembles a wave or a stylized mountain range.

2555 Davie Road • Ft. Lauderdale, FL 33317 Phone [phone] • Fax [phone] www.makosurgical.com

#### 510(K) SUMMARY

| Submitter: | MAKO Surgical Corp. |
|----------------------------------|--------------------------------------------|
| Address: | 2555 Davie Road, Fort Lauderdale, FL 33317 |
| Phone number/ Fax Number: | (Ph) 954-628-0665; (F) 954-927-0446 |
| Contact Person: | Jonathan Reeves |
| Date Prepared: | January 29, 2015 |
| Proprietary Name:<br>Knee System | The RESTORIS™ Multicompartmental (MCK) |
| Common Name: | Partial Knee System |
| Classification: | Class II |

#### Product Codes/Classification #:

| Code of Federal<br>Regulations | Product<br>code | Description |
|--------------------------------|-----------------|-----------------------------------------------------------------------------------------------|
| 21 CFR 888.3520 | HSX | Knee joint femorotibial metal/polymer non constrained<br>cemented prosthesis |
| 21 CFR 888.3530 | HRY | Knee joint femorotibial metal/polymer semi constrained<br>cemented prosthesis |
| 21 CFR 888.3540 | KRR | Knee joint patellofemoral polymer/metal semi<br>constrained cemented prosthesis |
| 21 CFR 888.3560 | NPJ | Knee joint patellofemorotibial polymer/metal/polymer<br>semi constrained cemented prosthesis |
| 21 CFR 888.3560 | OIY | Knee joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis. |

# Reason for 510(k) submission:

Special 510(k): Device modification with no change to fundamental scientific technology or intended use

# Device Modification:

- Addition of Highly Cross-linked UHMWPE (X3) onlay tibial insert ●
- Gas Plasma Sterilization ●
- . Packaging

## Device Description:

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RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).

- RESTORIS™ MCK Uni: ●
- o Unicompartmental femoral condyle components
- Unicompartmental tibial onlay components (tibial baseplate and tibial o onlay insert)
- Unicompartmental tibial inlay components o
- RESTORISTM MCK PF: o
- o Patellofemoral trochlear components
- o Patella components

The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multicompartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.

# Intended Use:

Restoris™ Multicompartmental Knee (MCK) System is indicated for single or multicompartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:

- Medial unicondylar
- · Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)

The RESTORIS™ Multicompartmental Knee System is for single use only and is intended for implantation with bone cement.

# Substantial Equivalence:

The RESTORIS Multicompartmental Knee System is substantially equivalent to the following 510(k) cleared devices.

| Device Name | Manufacturer | 510(k) # |
|-----------------------------------------|--------------|----------|
| RESTORIS Multicompartmental Knee System | MAKO | K133039 |

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### Technological Characteristics:

The RESTORIS™ Multicompartmental Knee System is similar to legally marketed devices listed previously in that they share the same indications for use, are manufactured from the same or similar material, have same design/technological characteristics and have performance characteristics adequate to withstand anticipated physiological loading.

#### Performance Data:

The RESTORIS™ Multicompartmental Knee System has been evaluated through nonclinical performance testing for:

- Insert Snaplock Strength o
- Tibial Insert / Baseplate Micromotion o
- Tibio-Femoral Range of Motion o
- o Tibio-Femoral Instability
- Tibio-Femoral Contact Area and Stress
- o Tibial Insert Fatigue
- Tibial Insert Wear ●
- Packaging Validation
- Gas Plasma Sterilization Validation
- 5 Year Aging o

#### Conclusions of Non-clinical Data:

The results of performance 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 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.