AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM

K063017 · Aesculap, Inc. · JDQ · Dec 27, 2006 · Orthopedic

Device Facts

• Record ID: K063017
• Device Name: AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: Dec 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap SternumFix Sternal Closure System is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

Device Story

SternumFix Sternal Closure System consists of titanium alloy (TiAl6V4) implantable single-use clamps and a dedicated applicator instrument. Used by surgeons in clinical settings for sternal stabilization following sternotomy or fracture. Device functions by clamping the sternum to provide mechanical fixation, promoting bone fusion. Design leverages proven features of the Aesculap CranioFix system. Output is physical stabilization of the sternum. Benefits include effective sternal closure and fusion compared to traditional wire cerclage.

Clinical Evidence

Bench testing only. Mechanical testing compared the SternumFix system against the predicate Ethicon Stainless Steel Suture wire to demonstrate efficacy in sternal fixation.

Technological Characteristics

Implantable single-use clamp; material: titanium alloy (TiAl6V4); includes dedicated applicator instrument; mechanical fixation principle; non-powered; sterile.

Indications for Use

Indicated for patients requiring primary or secondary sternal closure or repair following sternotomy or sternal fracture to stabilize the sternum and promote fusion.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Ethicon Stainless Steel Suture Wire (K931271/ K946173)
• Aesculap CranioFix Titanium Clamp System (K040864)
• Synthes Sternal Fixation System (K010943)

Submission Summary (Full Text)

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#### 510(k) SUMMARY (as required by 21 CFR 807.92) B.

#### Device Name 26 September 2006

DEC 2 7 2006

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 | DEC 27 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|--------|
| CONTACT: | Matthew M. Hull<br>610-984-9072 (phone)<br>610-791-6882 (fax) | |
| TRADE NAME: | SternumFix Sternal Closure System | |
| COMMON NAME: | Metallic Cerclage Fixation System | |
| CLASSIFICATION NAME: | Bone fixation cerclage | |
| REGULATION NUMBER: | 888.3010 | |
| PRODUCT CODE: | JDQ | |

# SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the SternumFix Sternal Closure System is substantially equivalent to:

- 1) Ethicon Stainless Steel Suture Wire (K931271/ K946173)
- 2) Aesculap CranioFix Titanium Clamp System (K040864)
- 3) Synthes Sternal Fixation System (K010943)

## DEVICE DESCRIPTION

The Aesculap Sternal Closure System consists of an implantable single use clamp made of titanium alloy (TiAl6V4) and a specially designed applicator instrument.

### INDICATIONS FOR USE

The Aesculap SternumFix Sternal Closure System is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

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एक प्रतिक्रियों को प्रति किया था। इस बार की मानी की में बाद में दिल्ली की में हो गया है।
एक बार की में दिल्ली की में हो गई है। होगी की है और किसी है और किसी है और किसी है

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K063017
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# TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

The design of the clamp and the applier are based upon the proven design features of the Aesculap CranioFix clamp and applier. The implant material (TiAl4V6) is the same as that used in the CranioFix implant. The packaging and sterilization are the same as that used for CranioFix as well. The efficacy of the SternumFix was compared to that of the current standard of care: wire cerclage fixation (Ethicon SS Suture). The indicated use for this device is similar to that of the Synthes Sternal Fixation System.

### PERFORMANCE DATA

Mechanical testing of the SternumFix and the predicate Ethicon Stainless Steel proved the efficacy of the new device.

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Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. % Mr. Matthew M. Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

DEC 2 7 2006

Re: K063017

Trade/Device Name: SternumFix Sternal Closure System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: September 29, 2006 Received: October 2, 2006

Dear Mr. Hull:

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

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#### Page 2 - Mr. Matthew M. Hull

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 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,

Barbara Bouchind

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

Enclosure

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Page 1 of 1

#### INDICATIONS FOR USE STATEMENT A.

510(k) Number: K063017

Device Name:

Indications for Use:

The Aesculap SternumFix Sternal Closure System is intended for use in primary or secondary closure/ repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

X Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bridum

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

K063017 510(k) Number