SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM

K050041 · Synthes (Usa) · JDQ · Feb 25, 2005 · Orthopedic

Device Facts

• Record ID: K050041
• Device Name: SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JDQ · Orthopedic
• Decision Date: Feb 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes (USA) Sternal Fixation System (SFS) 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

Synthes Sternal Fixation System (SFS) provides mechanical stabilization of sternum. System components include machined titanium plates, quick-release pins, and 3.0mm locking screws. Device used by surgeons in clinical settings (OR) for sternal closure/repair post-sternotomy or fracture. Surgeon applies plates to sternum using screw fixation to create rigid construct. Stabilization promotes bone fusion. Sterile delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Machined titanium. Components: Plates, quick-release pins, 3.0mm locking screws. Principle: Mechanical bone fixation via screw-plate construct. 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

• Synthes Sternal Fixation System

Submission Summary (Full Text)

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K05 0041

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FEB 25 2005

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| 3.0 | 510(k) Summary | Page 1 of 1 |
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| | Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Device Name: | Synthes Sterile Sternal Fixation System (Sterile) |
| | Classification: | 888.3010 - Cerclage, Fixation , Metallic (JDQ)<br>888.3030 - Plate, Fixation, Bone, Non-Spinal, Metallic (HRS)<br>888.3040 - Screw, Fixation, Bone, Non-Spinal, Metallic (HWC) |
| | Predicate Devices: | Synthes Sternal Fixation System |
| | Device Description: | The Synthes SFS is a system consisting of machined Titanium<br>plates, a quick-release pin, and 3.0mm locking screws. The plates<br>utilize screw fixation to create the construct. |
| | Intended Use: | The Synthes (USA) Sternal Fixation System (SFS) is intended for<br>use in primary or secondary closure/ repair of the sternum<br>following sternotomy or fracture of the sternum to stabilize the<br>sternum and promote fusion. |
| | Substantial<br>Equivalence: | Comparative information presented supports substantial<br>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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2005

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

Re: K050041

Trade/Device Name: Synthes (USA) Sterile Sternal Fixation System Regulation Number: 21 CFR 888.3010, 21 CFR 888.3030, 21 CFR 888.3040 Regulation Name: Bone Fixation cerclage;Single/multiple component metallic bone fixation appliances and accessories; Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDQ, HBS, HWC Dated: January 4, 2005 Received: January 11, 2005

Dear Ms. Boyle:

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 10 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. Lisa M. Boyle

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,

Miriam C. Purist

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

510(k) Number (if known):

K050041

Device Name:

2.0

Synthes (USA) Sterile Sternal Fixation System

Indications for Use:

The Synthes (USA) Sterile Sternal Fixation System (SFS) 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.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C Provost

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

**510(k) Number** K050041