PIGALILEO TKR BASE V2.3 AND CAS V4.1

K090313 · Smith & Nephew, Inc. · OLO · Mar 11, 2009 · Neurology

Device Facts

• Record ID: K090313
• Device Name: PIGALILEO TKR BASE V2.3 AND CAS V4.1
• Applicant: Smith & Nephew, Inc.
• Product Code: OLO · Neurology
• Decision Date: Mar 11, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Smith & Nephew PiGalileo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.). Examples of surgical procedures include but are not limited to: - Total knee replacement supporting bone referencing technique - Total knee replacement supporting ligament balancing technique - Minimally invasive total knee replacement

Device Story

Software-controlled electromechanical stereotaxic navigation system; assists surgeons in total knee arthroplasty. Inputs: intra-operative anatomical landmarks, ligament tension data, limb alignment measurements. Operation: processes spatial data to guide instrument positioning for bone cuts and implant placement. Output: real-time navigation guidance displayed to surgeon. Used in OR by orthopedic surgeons. Benefits: improved accuracy in implant positioning and ligament balancing; supports minimally invasive techniques.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Software-controlled stereotaxic navigation system; electromechanical; 21 CFR 882.4560; Class II; Product Code OLO.

Indications for Use

Indicated for patients undergoing total knee replacement surgery requiring computer-assisted navigation for bone cuts, implant positioning, and ligament balancing.

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.

Submission Summary (Full Text)

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

# 1090313

## Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo Total Knee Replacement (TKR) CAS V4.1 and Base V2.3

MAR 1 2009

Total Knee Replacement (TKR) CAS V4.1 and base V2.3

Date of Summary: 02/05/2009

Contact Person and Address Mandy Coe Regulatory Affairs Specialist Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: Smith & Nephew PiGalileo Total Knee Replacement [TKR] Software Applications CAS V4.1 and Base V2.3

Common Name: PiGalileo Total Knee Software

#### Device Description

The PiGalileo Navigation System is a software-controlled electromechanical stereotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.

The PiGalileo TKR CAS V4.1 and Base V2.3 software applications are surgical techniques for computer assisted navigation that leverages PiGalleo Total Khee Replacement (TKR) instruments as well as a number of non-navigated knee instruments with the intent to optimally position knee prostheses during total joint arthroplasty.

#### Device Classification

21 CFR 882.4560 Stereotaxic Instrument - Class II

#### Indications for Use

The Smith & Nephew PiGalleo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.).

Examples of surgical procedures include but are not limited to:

- Total knee replacement supporting bone referencing technique �
- . Total knee replacement supporting ligament balancing technique
- Minimally invasive total knee replacement .

#### Substantial Equivalence Information

The overall software design and the instruments used with Smith & Nephew PiGalileo Total Knee Replacement (TKR) CAS V4.1 and Base V2.3 software applications are substantially equivalent to the previously cleared applications listed below:

| THE THE TECH JALLER FOR<br>"LE LEAR RE. 15 . 18 . 19 . 19 . 13 . 13 . 13 . 13 . 13 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 . 1 .<br>. IBE PAR<br>CARTERIAL AND AND ALM SER COLLECT AND CONSULTS AND COLLECT CALL COL<br>Mal plan to a minder and securities and a<br>Children and Children Carder Carder Bell Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Call Collection Collection C | .<br>.<br>CHARLESSION FOR UNLERSER UNDER I W HERE S SHERE S SHE<br>AND ENLINE ENE SPECIE THE REMES .<br><br>BELLER BAND SELECT COLLECT COLLECT COLLECT COLLECT COLLECT COLLECTES COLLECTES COLLECTED COLLECTED COLLECTED COLLECTED COLLECTED COLLECTED COLLECTED COLLECTED COLLECTED COLLE<br>.<br>Види в мал и компаниции и в полнии в книжни и книжник как в<br>M Trill I<br><br>--------------------------------------------------------------------------------------------------------------<br>alle to the new . " worker will a " a " would wounder of the call of collection<br>per control and the contribution of the more of the mail of the more of the some of the send the later of<br>.6411 8811 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 | SECURE FRE. 1991 1991 1991 1991 1991 1981 1991 1991 1991 1991 1<br><br>.<br>.<br>FAR MAR ED S.PIRE . B. ERCHEN FLE Full . BUT IN E. BAT HIBL LA . M. CALCAL . LA<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Carrely Contract Concession I<br> |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------ | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

11

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

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

MAR I I 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mandy Coe Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116

Re: K090313

Trade/Device Name: PiGalileo Total Knee Replacement (TKR) Software Applications CAS V4.1 and Base V2.3

Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: February 6, 2009 Received: February 9, 2009

Dear Mandy Coe:

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.

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

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

Page 2 - Mandy Coe

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 Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (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 Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Ln Ahmed. for.

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

Enclosure

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

# 510(k) Number (if known): K09 0313

Device Name: PiGalileo Total Knee Replacement (TKR) Software Applications CAS V4.1 and Base V2.3

## Indications for Use:

The Smith & Nephew PiGalileo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.).

Examples of surgical procedures include but are not limited to.

- Total knee replacement supporting bone referencing technique
- Total knee replacement supporting ligament balancing technique
- Minimally invasive total knee replacement

Prescription Use (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)

Neil R.S. Ogden Forman

Division of General, Restorative, and Neurological De

510(k) Number

Page 1 of 1