SYNTHES (USA) STERNAL FIXATION SYSTEM

K052683 · Synthes (Usa) · HRS · Dec 5, 2005 · Orthopedic

Device Facts

• Record ID: K052683
• Device Name: SYNTHES (USA) STERNAL FIXATION SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Sternal Fixation 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

Synthes Sternal Fixation System consists of titanium locking plates designed for sternal stabilization. Plates feature compression screw holes compatible with 2.4mm and 3.0mm locking screws; notched sides and undersides facilitate placement. Available in 96mm and 160mm lengths with 12 or 20 holes. Used by surgeons in clinical settings for sternal closure or repair following sternotomy or fracture. Device provides mechanical stabilization to promote bone fusion. Output is physical fixation of the sternum.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Titanium locking plates; 2.4mm and 3.0mm locking screw compatibility; notched plate design; lengths of 96mm and 160mm; 12 and 20 hole configurations. Mechanical fixation device.

Indications for Use

Indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture to stabilize the sternum and promote fusion. Contraindicated for use in acute cardiac patients.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Sternal Fixation Systems

Submission Summary (Full Text)

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3.0

K052683 (pg 1 of 1

## DEC 5 2005

| 510(k) Summary | DEC 5 2005<br>Page 1 of 1 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes Sternal Fixation System |
| Classification: | 21 CFR 888.3030: Plate, fixation, bone, non-spinal |
| Predicate Devices: | Synthes Sternal Fixation Systems |
| Device Description: | The Synthes Titanium Locking Plates feature compression screw<br>holes which accept existing 2.4 and 3.0mm locking screws, have<br>notched sides and undersides. The plates are available in lengths<br>of 96 and 160mm with 12 and 20 holes. |
| Intended Use: | The Synthes Sternal Fixation System is intended for use in primary<br>or secondary closure/repair of the sternum following sternotomy o<br>fracture of the sternum to stabilize the sternum and promote fusion |
| | CONTRAINDICATIONS<br>The Synthes Titanium 2.4mm Universal Locking Plates are contra-<br>indicated for use in acute cardiac patients. |
| Substantial<br>Equivalence: | 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 and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 5 2005

Lisa Boyle Regulatory Specialist Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K052683

Trade/Device Name: Synthes Sternal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II

Product Code: HRS Dated: November 2, 2005 Received: November 9, 2005

Dear Ms. Boyle:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 nteredments, 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 approvisions of the Act. The general controls provisions of the Act include requirements for annual provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your devices is classified (see above) into either class II (Special Controls) or class III (PMA), they 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 devices comply 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 -Lisa Boyle

This letter will allow you to begin marketing your devices as described in your Section 510(k) This letter will and would began mains of substantial equivalence of your devices to a legally promation notificate device results in a classification for your device and thus, permits your devices to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dome office of Compliance at [phone]. Also, please note the regulation entitled, Contact the Office of Courter of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general intermational 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,

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

Enclosure

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## K052683

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## Indications for Use

510(k) Number (if known):

KOSZ683

Device Name:

2.0

Synthes (USA) Sternal Fixation System

Indications for Use:

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

CONTRAINDICATIONS

The Synthes Titanium 2.4mm Universal Locking Plates are contraindicated for use in acute cardiac patients.

X Prescription Use (Per 21 CFR 801.109)

.

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)

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

| 510(k) Number | K052683 |
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