SYNTHES STERNAL FIXATION SYSTEM

K112689 · Synthes, Inc. · HRS · Oct 26, 2011 · Orthopedic

Device Facts

• Record ID: K112689
• Device Name: SYNTHES STERNAL FIXATION SYSTEM
• Applicant: Synthes, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 26, 2011
• 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. The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated 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. Contraindications: The Synthes Titanium 2.4 mm Universal Locking Plates are contraindicated for use in acute cardiac patients.

Device Story

Synthes Sternal Fixation System consists of machined titanium plates, quick-release pins, and 3.0 mm locking screws. Device used by surgeons in clinical settings to stabilize sternum following sternotomy or fracture. Plates are affixed to bone via screw fixation to create construct, promoting fusion. System provides mechanical stabilization of sternal segments.

Clinical Evidence

No clinical data was needed for this device; bench testing only.

Technological Characteristics

System comprises machined titanium plates, quick-release pins, and 3.0 mm locking screws. Utilizes screw fixation for bone stabilization. No software or electronic components.

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. Contraindicated for 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 System (K093772)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Synthes CMF. The logo consists of the Synthes symbol, the word "SYNTHES" with a registered trademark symbol, and the letters "CMF" below the word "SYNTHES". The logo is in black and white.

KII2689 に OCT 2 6 2011

## 2.2 510(k) Summary

| Name of Firm: | Synthes<br>1301 Goshen Parkway<br>West Chester, PA 19380 |
|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Elizabeth Kierzek<br>Associate Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | September 16, 2011 |
| Device Trade Name: | Synthes Sternal Fixation System |
| Device Generic Name: | Plate, fixation, bone |
| Product Code: | HRS, HWC |
| Regulation Number: | 888.3030, 888.3040 |
| Predicate Devices: | Synthes Sternal Fixation System (K093772) |
| Device Description: | The Synthes (USA) Sternal Fixation System consists of<br>machined titanium plates, a quick-release pin and 3.0<br>mm locking screws. The plates utilize screw fixation to<br>create the construct. |
| Intended Use /<br>Indications for Use: | The Synthes Sternal Fixation System is intended for<br>use in primary or secondary closure/repair of the<br>sternum following sternotomy or fracture of the<br>sternum to stabilize the sternum and promote fusion.<br>The Synthes (USA) Titanium 2.4 mm Universal<br>Locking Plates (12, 13 and 20 hole) are indicated for<br>use in primary or secondary closure/repair of the<br>sternum following stemotomy or fracture of the<br>sternum to stabilize the sternum and promote fusion.<br>Contraindications:<br>The Synthes Titanium 2.4 mm Universal Locking<br>Plates are contraindicated for use in acute cardiac<br>patients. |
| Comparison of the<br>technological<br>characteristics of the device<br>to the predicate device: | The design features, material, and indications for use of<br>the subject Sternal Fixation System are substantially<br>equivalent to the predicate devices identified.<br>Additionally, the safety and effectiveness of this<br>system is adequately supported by documentation<br>within this premarket notification. |
| Performance Data<br>(Nonclinical and/or<br>Clinical): | Clinical data was not needed for this device. |

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## @ SYNTHES * CMF

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Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a serif font.

OCT 2 6 2011

Synthes % Ms. Elizabeth Kierzek 1301 Goshen Parkway West Chester, PA 19380

Re: K112689

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, HWC Dated: October 4, 2011 Received: October 5, 2011

Dear Ms. Kierzek:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Elizabeth Kierzek

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty by router ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. p vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdaggov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunice Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 6

510(k) Number:

(if known)

Device Name: Synthes Sternal Fixation System

KII 2689

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 sternum to stabilize the sternum and promote fusion.

The Synthes (USA) Titanium 2.4 mm Universal Locking Plates (12, 13 and 20 hole) are indicated 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.

Contraindications:

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

Prescription Use X (21 CFR 801 Subpart D) AND / OR

Over-the-Counter Use (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)

Winhel Olsen for MWM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112689

CONFIDENTIAL