ORTHOMAP 3D 1.1 MODULE

K093206 · Stryker Corp. · OLO · Aug 4, 2010 · Neurology

Device Facts

• Record ID: K093206
• Device Name: ORTHOMAP 3D 1.1 MODULE
• Applicant: Stryker Corp.
• Product Code: OLO · Neurology
• Decision Date: Aug 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker Navigation System - OrthoMap 3D 1.1 Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions: • Import of multi-modality image data • Surgical planning, such as image manipulation and visualization and procedural planning • Surgical navigation, such as manual and automatic registration and precise positioning of instruments and implants

Device Story

Wireless optical tracking navigation system for orthopedic surgery; inputs include multi-modality image data; performs surgical planning, image manipulation, visualization, and procedural planning; provides intraoperative guidance via manual and automatic registration of rigid anatomical structures; enables precise positioning of instruments and implants; used in clinical settings by surgeons and trained staff; assists in orthopedic oncology, cam-type FAI, and ACL reconstruction; improves surgical accuracy and procedural outcomes.

Clinical Evidence

Evidence includes bench testing (software code review, functional, integration, safety, and accuracy testing), cadaveric verification studies for FAI and ACL treatments, and clinical confirmative trials for cam-type FAI. Results confirmed that system and clinical accuracy criteria were met and the system is safe and effective for the intended orthopedic procedures.

Technological Characteristics

Wireless optical tracking navigation system; comprises hardware and software for surgical planning and computer-assisted surgery. Supports multi-modality image data import. Software-based registration and navigation. Class II device under 21 CFR 882.4560.

Indications for Use

Indicated for patients undergoing orthopedic surgical procedures, including orthopedic oncology, cam type femoroacetabular impingement (FAI) surgery, and ACL reconstruction, where computer-assisted planning and intraoperative guidance are appropriate. Operated by trained surgeons and clinic staff.

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

• Stryker Navigation System OrthoMap® 3D Module (K083009)
• Stryker Navigation System Cranial Module (K062640)
• BrainLAB VectorVision® ACL (K042512)
• Medtronic Orthopaedic Trauma Application (K050651)

Submission Summary (Full Text)

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

# K093206

## 510(k) Summary

:

।

| 510(k) Owner: | Stryker Leibinger GmbH & Co. KG - Navigation<br>Bötzinger Straße 41<br>D-79111 Freiburg<br>Germany<br>(p) ([phone]<br>(f) ([phone] |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AUG 04 2010 |
| Registration No .: | 3007582679 |
| Contact Person: | Lilian Eckert<br>email: [e-mail]<br>Senior Regulatory Affairs Specialist |
| Date Summary Prepared: | July 29, 2010 |
| Device Trade Name: | Stryker Navigation System - OrthoMap® 3D 1.1 Module |
| Common Name: | Navigation System |
| Product Code: | OLO |
| Classification Name: | Orthopedic Stereotaxic Instrument |
| Title 21 CFR: | §882.4560 |
| Device Description: | The Stryker Navigation System - OrthoMap® 3D 1.1 Module is part of the<br>product series of the Stryker Navigation System. It is based on a wireless<br>optical tracking localization device. The system comprises of hardware and<br>software for surgical planning and computer assisted surgery. It supports<br>orthopedic oncology procedures, cam type FAI (femoroacetabular<br>impingement) surgery procedures and ACL (anterior cruciate ligament)<br>reconstruction procedures. |
| Indications for Use: | Intended Use:<br>The Stryker Navigation System - OrthoMap® 3D 1.1 Module is intended as a<br>planning and intraoperative guidance system to enable open or<br>percutaneous computer assisted surgery. The system is indicated for any<br>medical condition in which the use of computer assisted planning and<br>surgery may be appropriate. The system can be used for intraoperative<br>guidance where a reference to a rigid anatomical structure can be identified.<br>The system offers the following features and functions:<br>• Import of multi-modality image data<br>• Surgical planning, such as image manipulation and visualization and<br>procedural planning<br>• Surgical navigation, such as manual and automatic registration and<br>precise positioning of instruments and implants<br>Indications:<br>The system should be operated only by trained personnel such as surgeons<br>and clinic staff.<br>The system can assist surgeons in the following, but not limited to,<br>orthopedic surgical procedures:<br>• Orthopedic oncology procedures<br>• Cam type FAI (femoroacetabular impingement) surgery<br>• ACL (anterior cruciate ligament) reconstruction |

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

Substantial Equivalence:

Performance Testing

(Bench):

(Clinical):

The Stryker Navigation System - OrthoMap® 3D 1.1 Module is substantially equivalent in design, intended use and performance to the following predicate devices:

- Stryker Navigation System OrthoMap® 3D Module (K083009) .
- Stryker Navigation System Cranial Module (K062640) .
- BrainLAB VectorVision® ACL (K042512) .
- � Medtronic Orthopaedic Trauma Application (K050651)

The following verification and validation activities were performed:

- Bench testing according to Stryker Navigation's procedures for product . design and development. It includes software code reviews, component, functional, integration, safety and accuracy testing. It shows that the product meets the requirements. Also, it shows that no software anomalies impacting safety and effectiveness are known.
- Cadaveric verification studies evaluating the overall system and clinical . accuracy when used for FAI or ACL treatment. The analysis of the data revealed that the specified acceptance criteria for system and clinical accuracy can be reached for cam type FAI and ACL treatments.
- Performance Testing . Clinical confirmative trials: The system has been used clinically for cam type FAI treatments. The trials confirm the results of bench testing and the cadaveric verification study. They also show that the system can be used safely and effectively in the clinical environment.
- Comprehensive literature review discussing the safety and effectiveness . during usage of other navigation devices for FAI and ACL procedures. The review shows that other devices using equivalent characteristics and functionality can be used safely and effectively for cam type FAI and ACL procedures.
- The combination of the results of the bench testing, the cadaveric verification Conclusion: study, and the clinical confirmative trials demonstrate the safety and effectiveness of the system when used for the cam type FAI and ACL procedures. No new types of issues of safety and effectiveness are introduced by using this device.

The literature review and the comparison to the predicate devices show that the device makes use of equivalent technological characteristics and functionality and is intended for equivalent surgical procedures as compared to the predicate devices.

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

Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that appears to be three overlapping, curved lines, possibly representing a stylized human figure or a symbol related to health and human services. The image is in black and white and has a slightly distressed or aged appearance.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Stryker Leibinger GmbH & Co. KG % Ms. Lilian Eckert Senior Regulatory Affairs Specialist Bötzinger Straße 41 D-79111 Freiburg, Germany

AUG 0 4 2010

Re: K093206

Trade/Device Name: Stryker Navigation System - OrthoMap® 3D 1.1 Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: July 29, 2010 Received: August 02, 2010

Dear Ms. Eckert:

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

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

Page 2 - Ms. Lilian Eckert

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark N Milliken

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

Enclosure

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

510(K) Number (if known): K093206

## AUG 0 4 2010

Device Name: Stryker Navigation System - OrthoMap® 3D 1.1 Module

#### Intended Use:

The Stryker Navigation System - OrthoMap 3D 1.1 Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions:

- Import of multi-modality image data .
- Surgical planning, such as image manipulation and visualization and procedural planning .
- Surgical navigation, such as manual and automatic registration and precise. positioning of . instruments and implants

#### Indications:

The system should be operated only by trained personnel such as surgeons and clinic staff. The system can assist surgeons in the following, but not limited to, orthopedic surgical procedures:

- Orthopedic oncology procedures .
- Cam type FAI (femoroacetabular impingement) surgery
- ACL (anterior cruciate ligament) reconstruction

Over-The-Counter Use Prescription Use × - AND/OR . (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Nillfogle for mkm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093206