ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000

K083009 · Stryker Leibinger GmbH & Co KG · OLO · Feb 19, 2009 · Neurology

Device Facts

• Record ID: K083009
• Device Name: ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
• Applicant: Stryker Leibinger GmbH & Co KG
• Product Code: OLO · Neurology
• Decision Date: Feb 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Stryker Navigation System – OrthoMap® 3D 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 intra-operative guidance where a reference to a rigid anatomical structure can be identified.

Device Story

Stryker Navigation System - OrthoMap® 3D Module is a computer-assisted surgical planning and navigation system. Inputs include multi-modality image data (e.g., CT/MRI). System uses wireless optical tracking to localize instruments relative to rigid anatomical structures. Software enables segmentation of bony structures/pathology, distance/angular measurements, resection plane planning, and virtual screw placement. Intraoperatively, system provides real-time visualization of pre-planned volumes, resection planes, and instruments on a display. Used in OR by surgeons/clinic staff to guide orthopedic oncology procedures, including limb salvage and implant placement. Output assists surgeons in maintaining safety margins, assessing leg length/rotation, and verifying implant positioning. Benefits include improved surgical precision and anatomical visualization during complex orthopedic resections.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Wireless optical tracking localization device; software-based planning and navigation; multi-modality image data processing; supports DICOM-compliant image data; operates as a module within the Stryker Navigation System platform.

Indications for Use

Indicated for orthopedic oncology procedures requiring computer-assisted planning and intraoperative guidance. Supports surgical planning (segmentation, measurement, resection planning, virtual screw placement, annotation) and surgical navigation (visualization of volumes, resection planes, and screw placement relative to tracked instruments). For use 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

• Cranial Module (K062640)
• Spine & Fluoroscopy Module (K012380)

Submission Summary (Full Text)

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KOr3009

# FEB 1 9 2009

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| 3.0 510(k) Summary | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Stryker Navigation System - OrthoMap® 3D Module |
| Common Name: | Navigation System |
| Product Code: | OLO |
| Classification Name: | Stereotaxic Instruments |
| Title 21 CFR: | §882.4560 |
| Classification | ll |
| 510(k) Contact Person: | Lilian Eckert<br>Stryker Leibinger GmbH & Co. KG<br>Bötzinger Straße 41<br>D-79111 Freiburg<br>Germany<br>([phone]<br>email: [e-mail] |
| Date Summary Prepared: | Feburary 9, 2009 |
| Description: | The Stryker Navigation System - OrthoMap® 3D Module is<br>part of the product series of the Stryker Navigation System.<br>The system comprises software for surgical planning and<br>computer assisted surgery based on a wireless optical<br>tracking localization device for the use in navigated<br>orthopedic oncology surgery. |
| Intended Use: | The Stryker Navigation System - OrthoMap® 3D Module is<br>intended as a planning and intraoperative guidance system<br>to enable open or percutaneous computer assisted surgery.<br>The system is indicated for any medical condition in which<br>the use of computer assisted planning and surgery may be<br>appropriate. The system can be used for intra-operative<br>guidance where a reference to a rigid anatomical structure<br>can be identified. |
| Indications: | The system should be operated only by trained personnel<br>such as surgeons and clinic staff.<br>The Stryker Navigation System - OrthoMap® 3D Module<br>supports, but is not limited to, the following surgical<br>procedures: |
| | Orthopedic Oncology Procedures<br>Surgical Planning Procedures <ul><li>Segmentation to define volumes of interest using correlated, multi-modality image data, e.g. to assist outlining and visualizing bony structures such as aberrant pathology</li><li>Image based distance and angular measurement tools, e.g. to define and maintain safety margins to outlined</li></ul> |

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| | bony structures<br>Image based resection plane planning to define<br>resections relative to identified structures, e.g. to support<br>limb salvage surgery taking safety margins into account<br>Virtual screw placement planning in the image data with<br>variable screw length, head-length and diameter<br>Image based annotation point placement and<br>visualization, e.g. to support repositioning of bony<br>anatomic points during surgery |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Surgical Navigation Procedures |
| | Intra-operative visualization of volume image data<br>including visualization of pre-planned volumes of interest<br>relative to the tracked instrument, supporting navigated<br>excision of user-defined bony structures<br>Intra-operative visualization of resection planes relative<br>to the tracked instrument on bony structures assisting<br>bony resections<br>Intra-operative creation and visualization of annotation<br>points, supporting recording of landmarks on bony<br>anatomy, e.q. to assist oncology replacement prosthesis<br>repositioning, leg length and rotation assessment or<br>navigated implant placement<br>Navigated intra-operative screw placement based on<br>pre-planned or intra-operative virtual screw definition |
| Equivalent to: | K062640 Cranial Module<br>K012380 Spine & Fluoroscopy Module |
| Substantial Equivalence: | The Stryker Navigation System – OrthoMap® 3D Module<br>does not raise any new safety and efficacy concerns when<br>compared to similar devices already legally marketed.<br>Therefore, the Stryker Navigation System - OrthoMap® 3D<br>Module is substantially equivalent to these existing devices.<br>They will be designed and manufactured in accordance with<br>Stryker Leibinger's Quality Management System covered by<br>QSR 21CFR 820. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083009

Trade/Device Name: Stryker Navigation System - OrthoMap® 3D Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO . Dated: February 10, 2009 Received: February 13, 2009

FEB 1 9 2009

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 prodibitions againstansing and adulteration. Just

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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# Page 2 - Ms. Lilian Eckert

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Potmarler, Surveillance at [phone]. For questions regarding the reporting of device adverse vents. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Arsistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David Krane

-Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use Statement 2.0

510(K) Number (if known): K083009

Device Name: Stryker Navigation System = OrthoMap® 3D Module.

#### Intended Use

· The Stryker Navigation System – OrthoMap® 3D 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 intra-operative guidance where a reference to a rigid anatomical structure can be identified.

#### Indications for Use

The system should be operated only by trained personnel such as surgeons and clinic staff.

The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:

#### Orthopedic Oncology Procedures

Surgical Planning Procedures

- Segmentation to define volumes of interest using correlated, multi-modality . image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
- Image based distance and anqular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
- Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
- Virtual screw placement planning in the image data with variable screw length, bead-length and diameter
- Image based annotation point placement and visualization, e.q. to support repositioning of bony anatomic points during surgery

rgical Navigation Procedures

- Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
- Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
- Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
- Navigated intra-operative screw placement based on pre-planned or intraoperative virtual screw definition

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#### and/or Over-The-Counter Use Prescription Use × (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)

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Nil RP Syler
Firman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083009

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