SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM

K031508 · Synthes (Usa) · JDQ · May 30, 2003 · Orthopedic

Device Facts

• Record ID: K031508
• Device Name: SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JDQ · Orthopedic
• Decision Date: May 30, 2003
• 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 cable-based bone fixation system used for sternal repair and reconstruction. The system consists of stainless steel cables, cannulated screws, and plates. It provides surgeons with multiple configuration options, including cable-only, cable with cannulated screws, or a combination of cable, cannulated screws, and plates. The device is intended for use by surgeons in a clinical or operating room setting to stabilize the sternum following surgical procedures. By providing mechanical fixation, the system supports bone healing and structural integrity of the sternum.

Clinical Evidence

No clinical data provided; substantial equivalence is based on comparative information and design characteristics.

Technological Characteristics

System components include stainless steel cables, cannulated screws, and plates. The device functions as a mechanical bone fixation system. It is classified under 21 CFR 888.3010 (cerclage), 888.3030 (bone plate), and 888.3040 (bone screw).

Indications for Use

Indicated for sternal repair and reconstruction in patients requiring surgical sternal fixation.

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 Cerclage Wire (Pre-76)

Submission Summary (Full Text)

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MAY 3 0 2003

KC3/508

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## Summary of Safety and Effectiveness 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) Sternal Reconstruction System |
| CLASSIFICATION: | Class II § 21 CFR 888.3010: Cerclage, fixation<br>Class II § 21 CFR 888.3030: Plate, fixation, bone<br>Class II § 21 CFR 888.3040: Screws, fixation, bone |
| PREDICATE DEVICE: | Synthes Cerclage Wire (Pre-76) |
| DEVICE DESCRIPTION: | The Synthes Sternal Reconstruction System is a cable-based system<br>comprised of stainless steel cable, cannulated screws and plates. The<br>system is designed to allow for multiple sternal repair and reconstruction<br>options. It can be used as follows:<br><ul><li>Cable only</li><li>Cable and cannulated screws</li><li>Cable, cannulated screws, and plates</li></ul> |
| 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 is 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 three overlapping abstract shapes, possibly representing human figures or wings. The seal is black and white.

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ms. Lisa Boyle Regulatory Associate Synthes USA 1690 Russell Road Post Office Box 1766 Paoli, PA 19301

Re: K031508

Trade/Device Name: Syntehes (USA) Sternal Reconstruction System Regulation Number: 21 CFR 888.3010, 888.3030 and 888.3040 Regulation Name: Bone fixation cerclage, Single/multiple component metallic bone fixation appliances and accessories and Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDQ, HRS, HWE Dated: May 12, 2003

Received: May 14, 2003

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 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. Iisting 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

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## Page 2 - Ms. Lisa Boyle

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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/dsma/dsmamain.html

Sincerely vours.

Mark A. Milleson

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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## 2.0 Indications for Use Statement

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| 510(k) Number (if known): | K031508 |
|---------------------------|---------|
|---------------------------|---------|

Synthes (USA) Sternal Reconstruction System Device Name:

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

Mark A. Millman

Divis noof General, Restorative and Neurological Devices

510(k) Number -

Confidential