SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM

K031196 · Praxim · HAW · Jun 7, 2005 · Neurology

Device Facts

• Record ID: K031196
• Device Name: SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM
• Applicant: Praxim
• Product Code: HAW · Neurology
• Decision Date: Jun 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during: - Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model - Total Knee Arthroplasty with ZIMMER NEXGEN implant - UniKnee Arthroplasty with BIOMET OXFORD Phase III implant

Device Story

System tracks anatomical landmarks using optical localizer and reflective markers; inputs digitized anatomical data to mobile computer station. Software processes positional data to generate virtual 3D images for surgical planning and navigation. Used in OR by surgeons to guide ACL reconstruction and knee arthroplasty. Output displayed on screen to assist in locating structures and aligning implants. Benefits include improved surgical precision and alignment accuracy.

Clinical Evidence

Clinical study provided, alongside phantom and specimen bench testing. Bench testing evaluated accuracy. Electrical safety and electromagnetic compatibility testing performed.

Technological Characteristics

Mobile computer station with optical localizer; uses reflective markers for tracking. Software-based navigation system. No specific material standards or energy sources beyond standard electrical power mentioned. Connectivity via system components.

Indications for Use

Indicated for patients undergoing ACL surgery, Total Knee Arthroplasty (ZIMMER NEXGEN), or UniKnee Arthroplasty (BIOMET OXFORD Phase III) requiring stereotactic anatomical localization and endoprosthesis alignment.

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

• BrainLab Vector Vision CT-Free (K021306)
• OrthoSoft Navitrack System-Optical TKR CT-Less (K021760)

Submission Summary (Full Text)

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## JUN 7 - 2005

K 03//96

## 510(k) Summary

# for

# Surgetics ORTHO KNEELOGICS Navigation System

#### Submitter Name and Address 1.

- Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France
Contact Name: Stéphane Lavallée 33-4 76 54 95 03 Telephone:

Date Prepared: April 28, 2005

#### Device Name 2.

Surgetics ORTHO KNEELOGICS Navigation System Proprietary Name: Common/Usual Name: Image guided surgical navigation system Computed tomography x-ray system (accessory) Classification Name:

#### 3. Predicate Device

BrainLab Vector Vision CT-Free (K021306) OrthoSoft Navitrack System-Optical TKR CT-Less (K021760)

#### 4. Intended Use

The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:

- Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of . potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant .
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant .

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#### 5. Device Description

Surgetics ORTHO KNEELOGICS Navigation System (ORTHO The KNEELOGICS) 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 . registration
- . ORTHO KNEELOGICS Navigation applications software

#### 6. Technological Characteristics and Substantial Equivalence

The Surgetics ORTHO KNEELOGICS Navigation System is substantially equivalent to other stereotaxic instruments that have been cleared for use in knee surgery without CT imaging, including the BrainLab Vector Vision CT-Free (K021306) and the OrthoSoft Navitrack System-Optical TKR CT-Less (K021760). The ORTHO KNEELOGICS and the predicate systems all acquire positional data by tracking reflective markers and digitizing the relative locations of anatomical landmarks, and then use this data to display virtual 3D images used for subsequent planning and navigation during surgery. The three systems can all be used with different manufacturer's implant components.

#### 7. Performance Testing

The Surgetics ORTHO KNEELOGICS Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and specimen bench testing and results of a clinical study were provided.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a symbol on the right and text on the left. The symbol is three curved shapes that resemble human profiles. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 7 - 2005

Praxim C/o Ms. Sheila Hemeon-Heyer, J.D., RAC Medical Device Consultants Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K031196

Trade/Device Name: Surgetics ORTHO KNEELOGICS Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 28, 2005 Received: April 29, 2005

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de nees that hat to been roll tequire approval of a premarket approval application (PMA). and Cosmetic Free, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, market of the Act include requirements for annual registration, listing of general controls provisions of vactice, 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 it indy be subject to back as a 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 i lease be devilsed that I Dr i issum that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I occrained and 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisms of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 -- Ms. Sheila Hemeon-Heyer, J.D., RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mainening of substantial equivalence of your device to a legally premarket notification: "The PDT Intently sification 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 II you desire specific advice ion your at [phone] . Also, please note the regulation entitled, Comacs the Office of Compuners (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

signature

Miriam C. Provost, Ph.D. Acting 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: K031196

Device Name: Surgetics ORTHO KNEELOGICS Navigation System

### Indications for Use:

The Surgetics ORTHO KNEELOGICS Navigation System is intended for use during stereotactic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for assisting the surgeon during:

- · Anterior Cruciate Ligament (ACL) surgery by estimating anisometry of potential insertion points based on a digitized anatomical model
- Total Knee Arthroplasty with ZIMMER NEXGEN implant
- UniKnee Arthroplasty with BIOMET OXFORD Phase III implant

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Euchth

ivision Sign-Off) Division Sign-On)
Division of General, Restorative
Oivision of General, Revices Division of Gical Devices

510(k) Number K031196

April 28, 2005