EXACTECH GPS

K152764 · Blue Ortho · HAW · Jul 13, 2016 · Neurology

Device Facts

• Record ID: K152764
• Device Name: EXACTECH GPS
• Applicant: Blue Ortho
• Product Code: HAW · Neurology
• Decision Date: Jul 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The EXACTECH GPS is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for primary and revision Total Knee Arthroplasty.

Device Story

EXACTECH GPS is an image-guided surgery (navigation) system for orthopedic procedures. It assists surgeons intraoperatively during total knee arthroplasty. The system acquires intraoperative data to compute and display distances, angles, and prosthetic component placement, helping surgeons identify and characterize bone cuts. It is used in the operating room by surgeons. The system provides visual feedback to guide surgical decision-making, aiming to improve the accuracy of component alignment and anatomical structure location. This submission introduces a revision total knee application and updates to sterile battery packaging.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including process qualifications for sterile battery packaging, shelf-life validation, and design verification/validation for the Revision Total Knee Application software, which included cadaveric sessions.

Technological Characteristics

Image-guided navigation system for orthopedic surgery. Utilizes localization technology to compute and display spatial data (distances, angles). Software-based system for intraoperative assistance. Modifications include sterile battery packaging and revision-specific software application. No changes to fundamental computer language or localization technology.

Indications for Use

Indicated for surgeons performing primary and revision Total Knee Arthroplasty to assist in locating anatomical structures and aligning endoprostheses.

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

• Exactech GPS (K100742)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope.

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

July 13, 2016

BLUE ORTHO Mr. Anthony Boyer President 5 avenue du Grand Sablon La Tronche, 38700 FRANCE

Re: K152764

Trade/Device Name: EXACTECH GPS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: June 9, 2016 Received: June 13, 2016

Dear Mr. Boyer:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

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/ResourcesforYou/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,

## Mark N. Melkerson -S

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) K152764

Device Name

## EXACTECH GPS

Indications for Use (Describe)

The EXACTECH GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

It is specifically indicated for primary and revision Total Knee Arthroplasty.

| Type of Use (Select one or both, as applicable) | <span> <b> <span style="text-decoration: underline;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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

[e-mail]

"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}------------------------------------------------

Image /page/3/Picture/0 description: The image is a logo for BlueOrtho, a company that specializes in augmented orthopedics. The logo features a blue square with a white "C" inside of it. To the right of the square is the company name, "BlueOrtho", in a sans-serif font. Below the company name is the tagline, "AUGMENTED ORTHOPAEDICS", in a smaller font.

5 Avenue du Grand Sablon 38700 La Tronche France

## BLUE NAVIGATION SYSTEM TRADITIONAL 510(k) – 510(k) Summary of Safety and Effectiveness

| Submission date: | June 09, 2016 |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | BLUE ORTHO<br>5 avenue du Grand Sablon<br>38700 La Tronche<br>France<br>Phone: [phone] |
| Contact | Anthony BOYER<br>Phone: [phone]<br>Cell: [phone]<br>[e-mail] |
| U.S.<br>Headquarters | Exactech, Inc.<br>2320 NW 66th Ct.<br>Gainesville, FL. 32653<br>Phone: [phone] |
| Trade Name | EXACTECH GPS |
| Common Name | Stereotaxic Instruments |
| Classification<br>Name | Stereotaxic Instrument (21 CFR 882.4560, Product Code OLO Class II) |
| Information on<br>devices to which<br>substantial<br>equivalence is<br>claimed: | 510(k) Number: K100742<br>Trade or Property Model Name: Exactech GPS<br>Manufacturer: BLUE ORTHO |
| Indications for<br>Use: | The EXACTECH GPS is intended for use during stereotaxic surgery to aid the<br>surgeon in locating anatomical structures and aligning the endoprostheses with<br>the anatomical structures.<br>It is specifically indicated for primary and revision Total Knee Arthroplasty. |
| Device<br>Description: | The EXACTECH GPS is an Image Guided Surgery, or Navigation, system for<br>orthopedic surgical procedures intended to be used to intraoperatively assist<br>surgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons to<br>acquire intraoperative data by computing and displaying information such as<br>distances, angles, and placement of prosthetic components in order to identify<br>and characterize bone cuts necessary to achieve surgical goals.<br><br>The predicate device is the EXACTECH GPS cleared in K100742. Both predicate<br>and proposed device have the same intended use, general design features, and<br>basic fundamental scientific technology. |
| | Compare to the predicate device cleared in K100742, this submission proposes<br>changes to:<br>- Sterile battery sterilization packaging<br>- Introduction of the Revision Total Knee Application software |
| Testing | Sterile battery:<br>- Process qualifications related to packaging and sterilization<br>- Shelf life validation<br><br>Revision Total Knee Application software:<br>- Design Verification (including accuracy testing)<br>- Design Validation (including cadaveric sessions) |
| Summary of<br>Technological<br>Characteristics | The rationale for substantial equivalence is based on consideration of the<br>following characteristics:<br>- Intended Use: the proposed modifications do not affect device intended<br>use.<br>- General Design Features and Dimensions: the proposed modifications do<br>not affect key device features and dimensions.<br>- Shelf life of the sterile components: proposed and predicate devices have<br>the same shelf life.<br>- Basic fundamental scientific technology: the proposed modifications do not<br>change the device computer language and / or localization technology.<br>- Performance Specifications: the proposed modifications do not affect<br>device accuracy and / or performance. |
| Substantial<br>Equivalence<br>Conclusion | Proposed device was tested during engineering studies and testing ensures<br>Results of engineering studies and cadaveric sessions referenced in this 510(k)<br>submission demonstrate the proposed EXACTECH GPS is substantially equivalent<br>to the predicate. |

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

Image /page/4/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized blue "C" shape on the left, followed by the text "BlueOrtho" in a clean, sans-serif font. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size.

5 Avenue du Grand Sablon 38700 La Tronche France