Materialise PKA Guide System

K172650 · Materialise NV · HSX · Nov 20, 2017 · Orthopedic

Device Facts

• Record ID: K172650
• Device Name: Materialise PKA Guide System
• Applicant: Materialise NV
• Product Code: HSX · Orthopedic
• Decision Date: Nov 20, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2

Intended Use

The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems prostheses families only. The Materialise PKA Guides are intended for single use only.

Device Story

System uses patient MRI scans to generate pre-surgical plan via Materialise PKA Planner software; surgeon inspects, fine-tunes, and approves plan pre-operatively. Patient-specific templates (femur/tibia guides) are manufactured based on approved plan. Intra-operatively, surgeon uses guides to mark bone and guide cutting for partial knee replacement component positioning. System ensures accurate transfer of pre-operative plan to surgical site. Benefits include improved alignment and positioning of knee prosthesis components.

Clinical Evidence

Bench testing only. Previous testing for biocompatibility, cleaning, debris, and dimensional stability from predicate K112301 is applicable. Testing verified system accuracy and performance are adequate for intended use.

Technological Characteristics

Patient-specific surgical templates (femur/tibia guides) and bone models. Single-use. Software-based pre-surgical planning using MRI data. Manufactured in compliance with FDA 21 CFR 820 and ISO 13485 standards.

Indications for Use

Indicated for patients undergoing partial knee replacement surgery where anatomic landmarks for implant alignment are identifiable on imaging scans. Used with ZUK UNI, JOURNEY UNI, JOURNEY II UNI, and JZ (Hybrid) UNI knee systems.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• Zimmer Patient Specific Instruments System 3.0 (K112301)
• Materialise TKA Guide System (K162273)

Reference Devices

• Kuvia3D (K161559)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 20, 2017

Materialise NV Oliver Clemens Regulatory Officer Technologielaan 15. Leuven, BE 3001

Re: K172650

Trade/Device Name: Materialise PKA Guide System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, OOG Dated: September 5, 2017 Received: September 5, 2017

Dear Oliver Clemens:

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 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.

{1}------------------------------------------------

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K172650

Device Name Materialise PKA Guide System

#### Indications for Use (Describe)

The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems prostheses families only.

The Materialise PKA Guides are intended for single use only.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Materialise PKA Guide System 510(k) Premarket Notification

#### 510(k) Summary

# 510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

| Company name | Materialise N.V. |
|-----------------------------------|-----------------------------------|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | [phone] |
| Fax number | [phone] |
| Principal Contact person | Oliver Clemens |
| Contact title | Regulatory Affairs Officer |
| Contact e-mail address | [e-mail] |
| Additional contact person | Wim Claassen |
| Contact title | Portfolio Manager |
| Contact e-mail address | [e-mail] |

#### Submission date

The date of the Traditional 510(k) submission is August 25, 2017

### Submission information

| Trade Name | Materialise PKA Planner<br>Materialise PKA Guide<br>Visionaire UNI cutting guides |
|--------------------------|-------------------------------------------------------------------------------------------------|
| Common Name | Knee prosthes is |
| Classification Name | Knee joint patellofemorotibial polymer /metal /polymer semi-<br>constrained cemented prosthesis |
| Primary product code | HSX (21 CFR 888.3520) |
| Subsequent product codes | OOG |

#### Predicate Devices

The primary predicate devices to which substantial equivalence is claimed:

Materialise N.V.

{4}------------------------------------------------

| Trade or proprietary or model name | Zimmer Patient Specific Instruments System 3.0 |
|------------------------------------|------------------------------------------------|
| 510(k) number | K112301 |
| Decision date | January 6th, 2012 |
| Classification product code | HSX (21 CFR 888.3520) |
| Subsequent product codes | OOG |
| Manufacturer | Materialise N.V. |

The secondary predicate device to which substantial equivalence is claimed:

| Trade or proprietary or model name | Materialise TKA Guide System |
|------------------------------------|------------------------------|
| 510(k) number | K162273 |
| Decision date | November 7th, 2016 |
| Classification product code | JWH (21 CFR 888.3560) |
| Subsequent product codes | MBH, OIY, OOG |
| Manufacturer | Materialise N.V. |

The reference device for the cartilage color map functionality:

| Trade or proprietary or model name | Kuvia3D |
|------------------------------------|-----------------------------|
| 510(k) number | K161559 |
| Decision date | June 23rd, 2016 |
| Classification product code | LLZ (21 CFR 892.2050) |
| Manufacturer | 4QIMAGING, LLC DBA QMETRICS |

#### Device Description

Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.

{5}------------------------------------------------

# Materialise PKA Guide System 510(k) Premarket Notification

### 510(k) Summary

The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.

### Intended Use

The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems prostheses families only.

The Materialise PKA Guides are intended for single use only.

### Functioning of the Device

The Materialise PKA Guide System generates a pre-surgical plan based on MRI images using the Materialise PKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise PKA Guides are designed and manufactured based on the approved presurgical plan. Materialise PKA Guides are patient specific templates which transfer the pre-operatively determined positioning of the chosen partial knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual partial knee replacement components by guiding the marking of bone before cutting and to guide cutting of the bone.

#### Technological Characteristics

A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the primary predicate devices.

#### Performance Data

Previous testing for biocompatibility, cleaning, debris and dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate Zimmer Patient Specific Instruments System (K112301) and therefore previous cadaver testing on predicate device K112301 is considered applicable to the subject device.

#### Summary

The characteristics that determine the functionality and performance of the Materialise PKA Guide System are substantially equivalent to the devices cleared under K112301 and K162273. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates. The Materialise

{6}------------------------------------------------

Materialise PKA Guide System 510(k) Premarket Notification

# 510(k) Summary

PKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.