KNEEALIGN SYSTEM WITH REFERENCE SENSOR

K093998 · Orthalign, Inc. · OLO · Mar 22, 2010 · Neurology

Device Facts

• Record ID: K093998
• Device Name: KNEEALIGN SYSTEM WITH REFERENCE SENSOR
• Applicant: Orthalign, Inc.
• Product Code: OLO · Neurology
• Decision Date: Mar 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The KneeAlign™ System with Reference Sensor is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign™ System with Reference Sensor facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty/tibial resection .

Device Story

KneeAlign System with Reference Sensor is a non-invasive computer-assisted surgical navigation system for knee arthroplasty. Input: sensor data from a palm-sized computer module and reference sensor attached to instrumentation. Operation: device registers anatomical landmarks, calculates mechanical axes, and determines varus/valgus and posterior slope angles of cutting blocks. Output: graphical representation of instruments and anatomy on a display screen. Used in the OR by surgeons to guide tibial resection and implant positioning. Benefits: provides objective angular measurements to improve alignment accuracy compared to visual/tactile estimation. System consists of a single-use computer module and reusable instrumentation.

Clinical Evidence

No clinical trial data provided. Evidence consists of bench testing (system accuracy, performance, laser testing), software validation, cleaning/sterilization validation, biocompatibility assessment, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and simulated use/cadaver testing.

Technological Characteristics

System includes single-use computer module, reusable reference sensor, and reusable tibial jig. Sensing principle: triaxial angular measurement via sensor. Connectivity: standalone display. Software: algorithm-based spatial coordinate conversion. Sterilization: reusable components validated for cleaning/sterilization. Electrical safety: IEC 60601-1 compliant.

Indications for Use

Indicated for patients undergoing stereotactic orthopedic surgical procedures, specifically Total Knee Arthroplasty, to assist surgeons in determining reference alignment axes and positioning implants/instrumentation.

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

• KneeAlign System (K091411)
• BrainLAB Knee Essential (K073615)
• TOTAL KNEE SURGETICS Navigation System (K060282)

Submission Summary (Full Text)

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510(K) SUMMARY

# 11 093998

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

| Applicant | OrthAlign, Inc.<br>6 Cromwell<br>Suite 102<br>Irvine, CA 92618<br>Tel: [phone]<br>Fax: [phone] | MAR 2 2 2010 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Official<br>Correspondent | Amy Walters<br>AWE, Inc.<br>338 Vista Madera<br>Newport Beach, CA 92660<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] | |
| Trade Name | KneeAlignTM System with Reference Sensor | |
| Common Name | Stereotaxic Instrument | |
| Device<br>Classification | Class II, 21 CFR §882.4560 | |
| Product Codes | OLO: Orthopedic Stereotaxic Instrument | |
| Predicate devices | KneeAlign System (K091411)<br>BrainLAB Knee Essential (K073615)<br>TOTAL KNEE SURGETICS Navigation System<br>(K060282) | |

Substantially Equivalent To:

The KneeAlign™ System with Reference Sensor is substantially equivalent to the previously cleared KneeAlign System (K091411), BrainLAB Knee Essential(K073615), and TOTAL KNEE SURGETICS Navigation System (K060282).

Description of the Device Subject to Premarket Notification:

The KneeAlign System with Reference Sensor is an innovative non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign System is configured to detect, measure, and display angular measurement changes in a triaxial format.

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The current standard of care for knee arthroplasty procedures has the physician estimating these changes either by visual observation and tactile feedback or with assistance of computer assisted surgery devices. The KneeAlign System with Reference Sensor utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes. In knee arthroplasty procedures, the device assists the surgeon in establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to tibia. The KneeAlign System with Reference Sensor comprises a single use computer module and reusable instrumentation.

Indications for Use:

The KneeAlign System with Reference Sensor has the same indications for use as the previously cleared KneeAlign System (K091411).

The KneeAlign System with Reference Sensor is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlignSystem with Reference Sensor facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

- Total Knee Arthroplasty/tibial resection .
#### Technical Characteristics:

The KneeAlign™ System with Reference Sensor comprises a single use computer module, a reusable reference sensor, and reusable tibial jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical representation of instruments and anatomy on the user display screen. .

## Performance Data:

Simulated use testing confirms that the KneeAlign System with Reference Sensor can be used according to its intended use. The KneeAlign System with Reference Sensor has been verified and validated according to OrthAlign's procedures for product design and development. The safety and performance of the KneeAlign System with Reference Sensor has been validated to insure it meets its intended use, including:

- Bench Testing: System accuracy testing, performance testing, laser . testing
- . Software Validation
- l Cleaning and Sterilization Validation
- I Biocompatibility Assessment
- . Electrical Safety and Electromagnetic Compatibility Testing
- . Safety Requirements for Medical Electrical Equipment (IEC

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60601-1)

- . Electromagnetic Compatibility (EMC) Requirements (IEC 60601-1-2), and
- Simulated Use/Cadaver Testing ■

This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use.

The information provided by OrthAlign in this 510(k) application was found to be substantially equivalent to predicate devices such as the KneeAlign System (K091411), BrainLAB Knee Essential (K073615) and the TOTAL KNEE SURGETICS Navigation System (K060282).

#### Basis for Determination of Substantial Equivalence:

A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign System with Reference Sensor to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem consisting of three human profiles facing right, overlaid and connected, representing the department's focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

### MAR 2 2 2010

OrthAlign, Inc. % AWE, Inc. Ms. Amy Walters 338 Vista Madera Newport Beach, California 92660

Re: K093998

Trade/Device Name: KneeAlign™ System with Reference Sensor Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 01, 2010 Received: March 03, 2010

Dear Ms. Walters:

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 Foond, Or ve 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 lindility 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

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Page 2 - Ms. Amy Walters

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/CDRH/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Radiological Health

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

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K093998

Device Name: KneeAlign™ System with Reference Sensor

Indications for Use:

The KneeAlign™ System with Reference Sensor is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign™ System with Reference Sensor facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to:

- Total Knee Arthroplasty .
Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mireal formkn

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(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093998

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