SIMMETRY SACROILIAC JOINT FUSION SYSTEM

K130092 · Zyga Technology, Inc. · OUR · Feb 27, 2013 · Orthopedic

Device Facts

• Record ID: K130092
• Device Name: SIMMETRY SACROILIAC JOINT FUSION SYSTEM
• Applicant: Zyga Technology, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Feb 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

SImmetry Sacroiliac Joint Fusion System consists of cannulated titanium alloy screws (6.5mm-12.5mm diameter; 30mm-70mm length) and titanium washers. Device provides mechanical fixation to facilitate sacroiliac joint fusion. Used by surgeons in clinical settings to treat sacroiliac joint disruptions and degenerative sacroiliitis. Modifications in this submission include addition of a washer component, surface finish changes, thread profile adjustments, and drive feature updates. Device functions via mechanical stabilization of the joint; no software or algorithmic components involved.

Clinical Evidence

Bench testing only. Bending fatigue testing performed per ASTM F1264 and torsion testing performed per ASTM F543. Results confirm mechanical performance is equivalent or superior to the predicate device.

Technological Characteristics

Cannulated bone screws and washers. Material: Titanium Alloy (Ti-6Al-4V ELI). Dimensions: 6.5mm-12.5mm diameter, 30mm-70mm length. Mechanical fixation principle. Testing standards: ASTM F1264 (bending fatigue), ASTM F543 (torsion).

Indications for Use

Indicated for patients requiring sacroiliac joint fusion due to sacroiliac joint disruptions or degenerative sacroiliitis.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• SImmetry Sacroiliac Joint Fusion System (K111801)

Submission Summary (Full Text)

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## K130092

510(k) Summary and Certification

#### [As required by 21 CFR 807.92(c)]

#### 1. Submitter / Contact Person / Date of Preparation

| Submitter | Zyga Technology, Inc.<br>700 10th Ave South<br>Minneapolis, MN 55415-1745 |
|---------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Diane Brinza<br>Director of Regulatory Affairs<br>Ph. 612.455.1061, ext. 104<br>Fax. [phone] |
| Date of Preparation | January 11, 2013 |

### 2. General Information

| Trade Name | SImmetry® Sacroiliac Joint Fusion System |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual<br>Name | Fixation Device/Bone Screw |
| Classification | Smooth or threaded metallic bone fixation fastener<br>Product Code, OUR<br>21 CFR § 888.3040<br>Class II |
| Manufacturer | Zyga Technology, Inc.<br>700 10th Ave South Suite 20<br>Minneapolis, MN 55415-1745 |
| Identification of<br>Predicate Devices | K111801<br>Zyga Technology, Inc.<br>SImmetry Sacroiliac Joint Fusion System |
| Reason for Premarket<br>Notification | This premarket notification addresses the addition of a new<br>washer component and geometrical modifications to the<br>device including modification of the surface finish, thread<br>profile, and drive features for the implant. |

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| Device Description | The SImmetry Sacroiliac Joint Fusion System consists of<br>cannulated screws available in titanium having diameters<br>ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm;<br>titanium washers are available for the 6.5mm diameter<br>screws. | |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use /<br>Indications for Use | The SImmetry® Sacroiliac Joint Fusion System is intended<br>for sacroiliac joint fusion for conditions including sacroiliac<br>ioint disruptions and degenerative sacroiliitis. | |
| Technological<br>Characteristic | The principle of operation and fundamental scientific<br>technology of the subject devices is identical to that of the<br>identified predicate. | |
| Materials | The subject devices are manufactured from Titanium Alloy<br>(Ti-6Al-4V ELI). | |
| Technological<br>Comparison . | The modification of the SImmetry Sacroiliac Joint Fusion<br>System does not represent a change in technological<br>characteristics from that of the indicated predicate device.<br>and therefore does not raise any new questions of safety or<br>effectiveness. | |
| Summary of<br>Non-clinical<br>Performance Data | Non-Clinical bench tests were performed using the worst<br>case SImmetry implant in bending fatigue per ASTM F1264<br>and in torsion per ASTM F543. Results demonstrate that the<br>implants perform as well or better than the predicate<br>devices. | |
| Conclusion | Equivalence for the SImmetry Sacroiliac Joint Fusion<br>System is based on the same indications for use, design<br>features, operational principles, and material composition<br>and mechanical performance when compared to the<br>predicate device cleared under K111801. | |

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

February 27, 2013

Zyga Technology, Incorporated % Ms. Diane Brinza Director of Regulatory, Clinical and Quality Assurance 700 10th Avenue South, Suite 20 Minneapolis, Minnesota 55415-1745

Re: K130092

Trade/Device Name: SImmetry Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: February 1, 2013 Received: February 4, 2013

Dear Ms. Brinza:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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#### Page 2 - Ms. Diane Brinza

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

Sincerely yours,

ErinI.D.Keith

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

Enclosure

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| Attachment A | |
|--------------|-------------------------------|
| | Indications for Use Statement |

| 510(k) Number (if known) | K130092 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SImmetry Sacroiliac Joint Fusion System |
| Indications for Use | The SImmetry ^® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. |
| Prescription Use (Per 21 CFR 801.109) | √ |

| | OR | Over-The-Counter Use (21 CFR 801 Subpart C) |
|--|----|---------------------------------------------|
|--|----|---------------------------------------------|

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Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth 詞詞ank -S

Division of Orthopedic Devices

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