SYNTHES STERNAL ZIPFIX SYSTEM

K110789 · Synthes (Usa) · JDQ · Jul 28, 2011 · Orthopedic

Device Facts

• Record ID: K110789
• Device Name: SYNTHES STERNAL ZIPFIX SYSTEM
• Applicant: Synthes (Usa)
• Product Code: JDQ · Orthopedic
• Decision Date: Jul 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Sternal ZipFix™ 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 ZipFix™ System consists of PEEK Optima LT-3 cable ties with detachable stainless steel needles. Used in peristernal fashion through intercostal space to stabilize sternum following sternotomy or fracture. Physician inserts device using needle, removes needle, then tightens and secures cable tie to provide fixation. Device can be cut and removed for emergent or long-term re-entry. Provides stable fixation; promotes fusion; facilitates re-entry compared to traditional wire cerclage.

Clinical Evidence

No clinical testing was performed to support this submission. Bench testing included static and dynamic mechanical tests, cut-through resistance, simulated-use construct testing, needle pull-out force, creep testing, and tensioning/life cycle testing of the application instrument. Biocompatibility and cytotoxicity testing were performed on the finished device.

Technological Characteristics

Implants manufactured from PEEK Optima LT-3. System includes cable ties and detachable stainless steel needles. Mechanical fixation via tensioning. Biocompatible material. Non-cytotoxic. Tested for static/dynamic strength, fatigue, and creep.

Indications for Use

Indicated for 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

• Ethicon Stainless Steel Suture Wire (K931271)
• Ethicon Stainless Steel Suture Wire (K946173)
• Synthes Sternal Fixation System (K093772)

Submission Summary (Full Text)

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JUL 2 8 2011

| 3.0 | 510(k) Summary |
|-----|----------------|
|-----|----------------|

| Date Prepared | May 24, 2011 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | SYNTHES (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>United States of America |
| Contact | Andrea M. Tasker<br>[e-mail]<br>phone: [phone] |
| Trade Name | Synthes Sternal ZipFix™ System |
| Common Name | cerclage, fixation |
| Regulation Name | Bone Fixation Cerclage |
| Regulation Number | 21 CFR §888.3010 |
| Device Class | 2 |
| Review Panel | Orthopedic |
| Product Codes | Primary: JDQ |
| Predicate Devices | K931271- Ethicon Stainless Steel Suture Wire<br>K946173- Ethicon Stainless Steel Suture Wire<br>K093772 - Synthes Sternal Fixation System |
| Device Description | The Synthes Sternal ZipFix™ System consists of polyetheretherketone<br>(PEEK Optima LT-3) cable ties with detachable, stainless steel needle.<br>The ZipFix are placed in peristernal fashion through the intercostal<br>space, with the help of the detachable needle. Once inserted, the needle<br>is removed and the ZipFix™ are tightened and secured in place to<br>provide stable fixation of the sternum. The ZipFix™ can be cut and<br>removed for emergent, and long-term, re-entry through the sternum. |
| Intended Use | The Synthes Sternal ZipFix™ System is intended for use in primary or<br>secondary closure/repair of the sternum following sternotomy or fracture<br>of the sternum to stabilize the sternum and promote fusion. |
| Technological<br>Characteristics | The Synthes ZipFix™ Sternal System is similar to the predicate devices<br>in terms of intended use, principles of operation and mechanical<br>performance. The Synthes ZipFix™ Sternal System has the same<br>intended use as K093772 - Synthes Sternal Fixation System. The<br>Synthes ZipFix™ Sternal System has the same principles of operation as<br>K931271/ K946173- Ethicon Stainless Steel Suture Wire in that they<br>placed in peristernal fashion through the intercostal space, with the help<br>of the detachable needle and tightened and secured to provide stable<br>fixation of the sternum. The Synthes ZipFix™ Sternal System has had<br>equivalent or better performance compared to K931271/ K946173-<br>Ethicon Stainless Steel Suture Wire with respect to static loading<br>strength and stiffness, fatigue strength, resistance to cut-through, and<br>construct strength. |
| Clinical Testing<br>Data | No clinical testing was performed to support this submission. |
| Non-Clinical<br>Testing Data | Mechanical testing was performed to compare the Synthes ZipFix™<br>Sternal Fixation System to the predicated device, stainless steel surgical<br>wire, for sternal closure. The Sternal ZipFix™ and stainless steel wire<br>were compared based on single implant static and dynamic tests and cut<br>through resistance testing. Based on a worst case construct, simulated-<br>use construct testing was also performed compared to the predicate.<br>Needle pull-out force testing was performed on the Sternal ZipFix™<br>device to determine the amount of force required to remove the needle<br>from the implant. Creep testing was performed on the Sternal ZipFix™<br>device to determine the amount of deformation when held under a<br>constant load. The ZipFix™ application instrument was tested for<br>tensioning performance and life cycle testing.<br><br>The mechanical testing showed that Sternal ZipFix™ had equivalent or<br>better performance compared to stainless steel surgical wire with respect<br>to static loading strength and stiffness, fatigue strength, resistance to cut-<br>through, and construct strength. The Sternal ZipFix™ passed the<br>mechanical test acceptance criteria for needle pull out and creep testing.<br>The ZipFix™ application instrument passed the mechanical testing<br>acceptance criteria for tensioning performance and life cycle testing.<br><br>The new Synthes Sternal ZipFix™ System implants are manufactured<br>from (PEEK Optima LT-3). This material has a well-established<br>biocompatibility history. According to the results of biocompatibility<br>testing on the finished device, the biocompatibility requirements have<br>been met. Cytotoxicity testing was also performed on the finished device<br>after sterilization. The finished product was determined to be non-<br>cytotoxic. |

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Synthes (USA) % Ms. Andrea M. Tasker CMF Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380

JUL 2 8 2011

Re: K110789

Trade/Device Name: Synthes Sternal ZipFix™ System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Code: JDQ Dated: July15, 2011 Received: July 18, 2011

Dear Ms. Tasker:

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. Andrea M. Tasker

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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.fda.gov/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark H. Millican

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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K1107.89 510(k) Number (if known):

Device Name: Synthes Sternal ZipFix™ System

The Synthes Sternal ZipFix™ System is intended for use in primary or Indications for Use: secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

X Prescription Use (Per 21 CFR 801.109)

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)

Daniel Krane for MXM
(Division Sign-Off)

Division of Surgical. Orthopedit and Restorative Devices

§10(k) Number K110789

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