SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM

K033816 · Synthes (Usa) · JDQ · Mar 2, 2004 · Orthopedic

Device Facts

• Record ID: K033816
• Device Name: SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JDQ · Orthopedic
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.

Device Story

The Synthes Sternal Reconstruction System is a bone fixation device used for sternal repair and reconstruction. The modified system consists of a 1.0 mm stainless steel cable, 750 mm in length, featuring a detachable needle with a ferrule. The device is intended for use by surgeons in a clinical or operating room setting to provide mechanical fixation of the sternum. It functions as a cerclage system to stabilize the sternum during the healing process. The device is provided as a modification to the existing Synthes Sternal Reconstruction System.

Clinical Evidence

bench testing only

Technological Characteristics

1.0 mm stainless steel cable; includes detachable needle and ferrule; 750 mm length. Class II bone fixation cerclage device (21 CFR 888.3010).

Indications for Use

Indicated for patients requiring sternal repair and reconstruction.

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

• Synthes Sternal Reconstruction System

Submission Summary (Full Text)

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mar - 2 2004

Ko 33816
page 1 of 1

## Summary of Safety and Effectivencss Information [510(k) Summary] 3.0

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) Modification to Sternal Reconstruction System |
| CLASSIFICATION: | Class II § 21 CFR 888.3010: Cerclage, fixation |
| PREDICATE DEVICE: | Synthes Sternal Reconstruction System |
| DEVICE DESCRIPTION: | The Synthes modified Sternal Reconstruction System contains a 1.0 mm<br>stainless steel cable with detachable needle with ferrule The cable is 750<br>mm in length. |
| INTENDED USE: | Synthes (USA) Sternal Reconstruction System is intended for use in sternal<br>repair and reconstruction. |
| SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence. |

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure, with three curved lines forming the body and wings.

Public Health Service

MAR - 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K033816

Trade/Device Name: Modification to Synthes (USA) Sternal Reconstruction System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: December 8, 2003 Reccived: December 9, 2003

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamined 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 encrosure) to regary the Medical Device Amendments, or to conninered proc to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, devices that have been rechasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r va may, mererere, 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 olassinod (600 wor ols. Existing major regulations affecting your device can may be subject to back as a sateral 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 I lease of advised that 1 br over device complies with other requirements of the Act that I DT has made a acternmalations administered by other Federal agencies. You must or any I cacal 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 CITY art 6077, aboning (21 OFF egulation (21 CFR Part 820); and if applicable, the electronic north in the quality byticles (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Lisa M. Boyle

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icity will anow you to ocgin mailing of substantial equivalence of your device to a legally premarket notification. The PDF interessification 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 acreoliation at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Wholfanting by reference to premessponsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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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## Indications for Use Statement 2.0

Page __ 1 of

| 510(k) Number (if known): | K033816 |
|---------------------------|-------------------------------------------------------------|
| Device Name: | Modification to Synthes (USA) Sternal Reconstruction System |
| Indications: | |

Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

Miriam C. Provost

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

**510(k) Number** K033816