EQUESTRA FLUID DELIVERY SYSTEM

K043568 · Medtronic Sofamor Danek · HRX · Jan 25, 2005 · Orthopedic

Device Facts

• Record ID: K043568
• Device Name: EQUESTRA FLUID DELIVERY SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: HRX · Orthopedic
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.

Device Story

EQUESTRA™ Fluid Delivery System is a manual, single-use disposable instrument set; includes bone tamps and stylets. Designed for percutaneous delivery of commercially cleared bone cement to orthopedic surgical sites. Operated by surgeons in clinical settings. System reservoirs are supplied empty; device does not contain bone cement. Facilitates controlled cement injection during orthopedic procedures; assists in site preparation and delivery. Benefits include providing a dedicated, manual delivery mechanism for bone cement, improving procedural efficiency and precision for the surgeon.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual, single-use disposable orthopedic surgical instruments. Includes bone tamps and stylets. Non-powered. No materials specified.

Indications for Use

Indicated for use by surgeons to provide a percutaneous means of delivering legally cleared bone cement to the surgical site during orthopedic procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• EQUESTRA™ Fluid Delivery System (K040483)

Submission Summary (Full Text)

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K043568

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## EQUESTRA™ Fluid Delivery System 510(k) Summary December 2004

JAN 2 5 2005

| I. Company: | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 [phone] |
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Contact: Richard W. Treharne, PhD Senior Vice President Regulatory Affairs

II. Proprietary Trade Name: EQUESTRA™ Fluid Delivery System

#### Classification Name: Orthopedic Manual Surgical Instrument III.

IV. Regulation Number: 888.4540, 878.4800 and 878.4200

#### V. Product Description

The EQUESTRA™ Fluid Delivery System is designed to provide surgeons with a means to inject commercially cleared bone cement to the surgical site in orthopedic procedures. The EQUESTRA™ Fluid Delivery System does not contain any bone cement material, as this system only consists of general instruments.

The EQUESTRA™ Fluid Delivery System consists of a variety of general surgical instruments. The system reservoirs are supplied empty as the system itself does not include any bone cement. Included in the system are bone tamps and stylets. All of the system components are manual, single-use disposable instruments.

The purpose of this submission was to add modified instruments to the EQUESTRA™ Fluid Delivery System.

#### VII Indications

The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.

#### VIII Substantial Equivalence

Documentation was provided which demonstrated the subject EQUESTRA™ instruments to be substantially equivalent to the EQUESTRA™ Fluid Delivery System instruments previously cleared by the agency in K040483 (SE 07/23/04).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

JAN 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K043568

Trade/Device Name: EQUESTRA™ Fluid Delivery System Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX and HXG Dated: December 22, 2004 Received: December 27, 2004

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) is the enactment date of the Medical Device Amendments, or to conniner of Hay 2016 to 112) 2011 accordance with the provisions of the Federal Food, Drug, de nocs that have been resuire approval of a premarket approval application (PMA). and Costiere for (110) was the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains 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 If your device is elassined controls. Existing major regulations affecting your device can may be dayses to been it ween 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 r rease of acrised 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 or any 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 - Richard W. Treharne, Ph.D. .

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manisoning of substantial equivalence of your device to a legally premaired 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 If you desire specific advice for your 2011 5. Also, please note the regulation entitled, Colliact the Office of Compilance in (21 m) (21CFR Part 807.97). You may obtain Misblaining by reference to premains on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

uriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: EQUESTRA™ Fluid Delivery System

### Indications for Use:

The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.

Prescription Use X (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)

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number_Ko43568

00053