PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0

K083565 · Smith & Nephew, Inc. · HAW · Feb 20, 2009 · Neurology

Device Facts

• Record ID: K083565
• Device Name: PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
• Applicant: Smith & Nephew, Inc.
• Product Code: HAW · Neurology
• Decision Date: Feb 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Smith & Nephew PiGalileo Total Hip Replacement (THR) V3.0 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. hip center, pelvic plane etc.). Examples of surgical procedures include but are not limited to: - Primary total hip replacement - Revision hip surgery - Minimally invasive hip arthroplasty

Device Story

PiGalileo THR V3.0 is a software-controlled electromechanical stereotaxic navigation system; assists surgeons in total hip arthroplasty. System inputs include intra-operative anatomical landmarks (e.g., hip center, pelvic plane) and data from navigated surgical instruments. Software processes these inputs to provide real-time guidance for bone cuts and implant positioning. Used in OR by surgeons; provides visual feedback to guide instrument placement. Benefits include optimized implant positioning during primary, revision, or minimally invasive hip procedures.

Clinical Evidence

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

Technological Characteristics

Stereotaxic instrument (21 CFR 882.4560); software-controlled electromechanical system. Utilizes navigated surgical instruments and non-navigated hip instruments. Provides computer-aided navigation for orthopedic surgery.

Indications for Use

Indicated for patients undergoing primary total hip replacement, revision hip surgery, or minimally invasive hip arthroplasty requiring computer-assisted navigation for bone cuts and implant positioning.

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

• Plus Orthopaedics AG Total Hip Replacement (THR V2.5 Software) (K070731)

Submission Summary (Full Text)

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KOS 3565 R. la

# Smith & Nephew. Inc. Summary of Safety and Effectiveness PiGalileo Total Hip Replacement (THR) V3.0

Date of Summary: 11/25/2008

Contact Person and Address Gino Rouss Requlatory Affairs Manager Smith & Nephew Orthopaedics 1450 Brooks Road Memphis, TN 38116 [phone]

Name of Device: Smith & Nephew PiGalileo Total Hip Replacement (THR) Software Application V3.0 Common Name: PiGalileo Total Hip Replacement (THR) V3.0

### 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 PiGalleo THR V3.0 software application is a surgical technique for computer assisted navigation that leverages PiGalileo Total Hip Replacement (THR) instruments as well as a number of non-navigated hip instruments with the intent to optimally position hip prostheses during total joint arthroplasty.

#### Device Classification

21 CFR 882.4560 Stereotaxic Instrument - Class II

## Indications for Use

The Smith & Nephew PiGalileo Total Hip Replacement (THR) V3.0 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. hip center, pelvic plane etc.).

Examples of surgical procedures include but are not limited to:

- Primary total hip replacement
- 트 Revision hip surgery
- 미 Minimally invasive hip arthroplasty

#### Substantial Equivalence Information

The overall software design and the instruments used with Smith & Nephew PiGalileo Total Hip Replacement (THR) V3.0 software application are substantially equivalent to the previously cleared application listed below:

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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| Plus Orthonedics AG | otal Hip Replacement<br>(THR V2.5 Software) | K070731 | //31/07 |

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and recognizable.

APR - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. % Mr. Gino J. Rouss, MS Manager, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116

Re: K083565

Trade/Device Name: PiGalileo Total Hip Replacement (THR) Software Application V3.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 21, 2009 Received: January 22, 2009

Dear Mr. Rouss:

This letter corrects our substantially equivalent letter dated February 20, 2009.

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. Ilsting 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. Gino J. Rouss, MS

forth in the quality systems (OS) 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 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,

Ohians. for.
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

tot

# 510(k) Number (if known):

Device Name: PiGalileo Total Hip Replacement (THR) Software Application V3.0

### Indications for Use:

The Smith & Nephew PiGalileo Total Hip Replacement (THR) V3.0 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. hip.center, pelvic plane etc.). : ·

Examples of surgical procedures include but are not limited to:

- Primary total hip replacement .
X

- Revision hip surgery
- Minimally invasive hip arthroplasty

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 (CDDE) 1

Heald R.R. Ander- for mxn

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

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510(k) Number: K083565