STRYKER ORTHOPAEDICS RFID INSTRUMENTATION

K053348 · Howmedica Osteonics Corp. · HAW · Aug 4, 2006 · Neurology

Device Facts

• Record ID: K053348
• Device Name: STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
• Applicant: Howmedica Osteonics Corp.
• Product Code: HAW · Neurology
• Decision Date: Aug 4, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker Navigation System's Hip and Knee Modules during orthopedic surgery.

Device Story

Stryker® Orthopaedics RFID Instrumentation consists of manual surgical instruments embedded with passive radio-frequency identification (RFID) tags. These instruments are designed for use in orthopedic surgery in conjunction with the Stryker Navigation System. The passive RFID tags do not operate independently; they function only when integrated with the navigation system to provide tracking or identification data during surgical procedures. The system is used by surgeons in an operating room environment. The instrumentation facilitates navigation-guided orthopedic procedures, assisting the surgeon in precise instrument positioning and tracking during hip and knee surgeries.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and operational principle comparisons to predicate devices.

Technological Characteristics

Manual surgical instruments equipped with passive RFID tags. Operates as an accessory to the Stryker Navigation System. Passive RFID technology requires external navigation system energy to function. Materials and design are consistent with existing navigation-compatible orthopedic instrumentation.

Indications for Use

Indicated for use as accessories to the Stryker Navigation System's Hip and Knee Modules during orthopedic surgery.

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

• Hip and Knee Modules of the Stryker® Navigation System (K022365 and K010204)
• Smith and Nephew Image Guided Surgical Instruments (K033341)
• DePuy CAS Knee Instrumentation (K043223)

Submission Summary (Full Text)

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053348

## 510(k) Summary of Safety and Effectiveness . Stryker® Orthopaedics RFID Instrumentation Proprietary Name: Stryker® Orthopaedics RFID Instrumentation Common Name: Orthopedic Manual Surgical Instruments with RFID capability Classification Name and Reference: Stereotaxic instrument (Title 21 CFR §882.4560) Device Panel/Product Code: 84 HAW Proposed Regulatory Class: Class II For Information contact: Vivian Kelly, Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone] Date Summary Prepared: November 30, 2005

## Description

Stryker® Orthopaedics RFID Instrumentation are navigational compatible manual surgical instruments which contain radio-frequency identification (RFID) technology. The RFID tags on the instruments are passive and will not operate without the navigation system. These instruments will be used during orthopedic surgery in conjunction with the Stryker" Navigation System. The instrumentation will be maintained and distributed by Stryker® Orthopaedics, while the navigation system will be maintained and distributed by Stryker® Instruments.

#### Indications:

Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker Navigation System's Hip and Knee Modules during orthopedic surgery.

## Substantial Equivalence:

The Stryker® Orthopaedics RFID Instrumentation is substantially equivalent to other navigational compatible instruments in regards to intended use, design, materials, and operational principles. The following devices are examples of predicate devices: 1) Hip and Knee Modules of the Stryker® Navigation System (K022365 and K010204), 2) Smith and Nephew Image Guided Surgical Instruments (K033341) and 3) DePuy CAS Knee Instrumentation (K043223).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2006

Howmedica Osteonics Corporation % Ms. Vivian Kelly, RAC Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K053348

Trade/Device Name: Stryker® Orthopaedics RFID Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 27, 2006 Received: July 28, 2006

Dear Ms. Kelly:

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 - Ms. Vivian Kelly, RAC

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

sincerely yours,

Hubert Lemmens

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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s3348

# Indications for Use

510(k) Number (if known):

Device Name: Stryker® Orthopaedics RFID Instrumentation

Indications

Stryker® Orthopaedics RFID Instrumentation is intended for use as accessories to the Stryker® Navigation System's Hip and Knee Modules during orthopedic surgery.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Lunn

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

510(k) Number k053348