SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM

K053542 · Praxim S.A · HAW · Apr 10, 2006 · Neurology

Device Facts

• Record ID: K053542
• Device Name: SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM
• Applicant: Praxim S.A
• Product Code: HAW · Neurology
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures. Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

Device Story

Optically based surgical navigation system; tracks bone structures and surgical instruments via reflective markers and infrared camera. System generates 3D bone model by acquiring anatomical landmarks. Used in OR by surgeons to monitor lower limb axis during osteotomy. Provides real-time guidance for instrument tip and direction (e.g., screwdriver, awl). Assists surgeon in achieving precise alignment; improves procedural control. Comprises mobile Surgetics Station, optical localizer, ancillary instruments, and HTO monitoring software.

Clinical Evidence

Evidence includes electrical safety and electromagnetic compatibility testing, phantom accuracy testing, specimen bench testing, and clinical experience summaries. No specific clinical trial metrics (e.g., p-values, sensitivity) provided in summary.

Technological Characteristics

Optically based stereotaxic instrument. Uses infrared camera for localization. Components: mobile computer station, optical localizer, reflective markers, ancillary surgical instruments. Software: HTO Monitoring. Connectivity: Standalone navigation system. Sterilization: Not specified.

Indications for Use

Indicated for surgeons performing lower limb osteotomy procedures (open or closed wedge) to assist in controlling lower limb axis. Patient population not specified by age or gender.

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

• PRAXIM - Surgetics ORTHO KNEELOGICS navigation system (K031196)
• BrainLab -- VectorVision® Osteotomy (K042513)

Submission Summary (Full Text)

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# APR 1 0 2006

053542

## 510(k) Summary

### for Surgetics ORTHO OSTEOLOGICS navigation system

#### 1. Submitter Name and Address

Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France

Contact Name: Stéphane Lavallée Telephone: [phone]

Date Prepared: November 15th, 2005

#### 2. Device Name

| Proprietary Name: | SURGETICS ORTHO OSTEOLOGICS NAVIGATION<br>SYSTEM |
|----------------------|---------------------------------------------------|
| Common/Usual Name: | Image guided surgical navigation system |
| Classification Name: | Stereotaxic Instrument: 21 CFR 882.4560, Class II |

#### 3. Predicate Device

PRAXIM - Surgetics ORTHO KNEELOGICS navigation system (K 031196) BrainLab -- VectorVision® Osteotomy (K 042513)

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#### 4. Intended Use

The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.

Examples of orthopedic surgical procedures include, but are not limited to:

Open wedge osteotomy for the lower limb

Closed wedge osteotomy for the lower limb

#### 5. Device Description

.

The Surgetics ORTHO OSTEOLOGICS Navigation System consists of the following major components and subsystems:

- The Surgetics Station, consisting of a mobile computer system and an optical . localizer
- Ancillary instruments and reflective markers used for reference and . calibration.
- HTO Monitoring Software for, but not limited to open and closed wedge . osteotomy for the lower limb

#### 6. Technological Characteristics and Substantial Equivalence

The Surgetics ORTHO OSTEOLOGICS Navigation System is substantially equivalent to other stereotaxic instruments that have been cleared for use in spine, orthopedic and traumatology surgery, including the BrainLab Vector Vision Osteotomy and the PRAXIM - Surgetics ORTHO KNEELOGICS navigation The ORTHO OSTEOLOGICS and the predicate systems all acquire system. positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, to aid the surgeon in linear procedures. It allows the surgeon to locate surgical instruments' tip and direction (e.g. screwdriver, awl). The system uses an infrared camera for localization and guidance of surgical instruments during the procedure.

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### 7. Performance Testing

The Surgetics ORTHO OSTEOLOGICS Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms, specimen bench testing, and clinical experience with the system were provided.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2006

Praxim S.A. c/o Medical Device Consultants, Inc. Mr. Randy Veale 49 Plain Street North Attleboro, Massachusetts 02760

Re: K053542

Trade/Device Name: Ortho Osteologics navigation system Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: February 27, 2006 Received: March 6, 2006

Dear Mr. Veale:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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 - Mr. Randy Veale

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

sincerely yours,

demee

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

### 510(k) Number (if known): K053542

### Device Name: Surgetics ORTHO OSTEOLOGICS navigation system

### Indications for Use:

The Surgetics ORTHO OSTEOLOGICS navigation system is an optically based surgical navigation system. It is intended for use as an aid to the surgeon in tracking bone structures and instruments on a 3D model of the patient's bone which is generated through acquiring multiple landmarks. The system is indicated to assist a surgeon to control the lower limb axis during osteotomy procedures.

Examples of orthopedic surgical procedures include, but are not limited to: Open wedge osteotomy for the lower limb Closed wedge osteotomy for the lower limb

Prescription Use (Part 21 CFR 801 Subpart D)

Surgetics ORTHO OSTEOLOGIOS ) Number

AND / OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| Additional information K053542<br>February 27, 2006 | CONFIDENTIAL |