PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1

K082267 · Smith & Nephew, Inc. · HAW · Oct 29, 2008 · Neurology

Device Facts

• Record ID: K082267
• Device Name: PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
• Applicant: Smith & Nephew, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Smith & Nephew PiGalileo System TKR 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 utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.) Examples of some 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

PiGalileo Navigation System is a software-controlled stereotaxic device assisting surgeons in total knee arthroplasty. It processes intraoperative data, including anatomical landmarks, ligament tension, and limb alignment, to guide bone cuts and implant positioning. Used in the operating room by surgeons, the system provides real-time navigation information to optimize prosthesis placement. It supports bone referencing, ligament balancing, and minimally invasive techniques. By providing precise spatial guidance, the system aims to improve the accuracy of implant alignment, potentially enhancing surgical outcomes for patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Software-controlled stereotaxic navigation system. Components include specialized surgical instruments for total knee replacement. Operates via intraoperative data acquisition (anatomical landmarks, ligament tension, limb alignment). Connectivity and specific material standards are not detailed in the provided documentation.

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.

Predicate Devices

• PiGalileo Total Knee Replacement (TKR) System (K061362)

Submission Summary (Full Text)

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# ר 222808

### Smith & Nephew, Inc. Summary of Safety and Effectiveness PiGalileo TKR V2.1 and PiGalileo TKR CAS V4.0

## OCT 2 9 2008

Date of Summary: 07/11/2008

Contact Person and Address

Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: PiGalileo TKR V2.1 and TKR CAS V4.0 Common Name: PiGalileo TKR

#### Device Description

The PiGalileo Navigation System is a software-controlled sterotaxic 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 V2.1 and PiGalileo TKR CAS V4.0 applications are surgical techniques for computer assisted navigation that leverages PiGalileo Total Knee Replacement (TKR) instruments as well as a number of non-navigated knee instruments for total knee replacement 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 PiGalileo System TKR 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 utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.) Examples of some 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 instruments used with Smith & Nephew PiGalileo TKR CAS V4.0 applications are substantially equivalent to previously cleared device listed below:

| MANUFACTURER | DESCRIPTION | 510(K) | CLEARANCE DATE |
|---------------------|--------------------------------------------------|---------|----------------|
| PLUS Orthopedics AG | PiGalileo Total Knee<br>Replacement (TKR) System | K061362 | 10/06/06 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three distinct lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

### OCT 2 9 2008

Re: K082267

Trade/Device Name: PiGalileo TKR V2.1 and PiGalileo TKR CAS V4.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stercotaxic Instrument Regulatory Class: II Product Code: HAW Dated: October 24, 2008 Received: October 29, 2008

Dear Rishi Sinha:

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 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.

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### Page 2 - Rishi Sinha

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,

Mark M. Milliman

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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#### KOR2267 510(k) Number (if known):

Device Name: PiGalileo TKR V2.1 and PiGalileo TKR CAS V4.0

Indications for Use:

The Smith & Nephew PiGalileo System TKR 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 utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intraoperatively (e.g. ligament tension, limb alignment, etc.)

Examples of some 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 Deyice Evaluation (ODE)

Mark A. Millikan

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

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510(k) Number