SIMMETRY SACROILIAC JOINT FUSION SYSTEM

K110512 · Zyga Technology, Inc. · OUR · Mar 23, 2011 · Orthopedic

Device Facts

• Record ID: K110512
• Device Name: SIMMETRY SACROILIAC JOINT FUSION SYSTEM
• Applicant: Zyga Technology, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Mar 23, 2011
• 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 fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Device Story

SImmetry Sacroiliac Joint Fusion System consists of cannulated titanium alloy (Ti-6Al-4V ELI) screws (6.5mm-12.5mm diameter; 30mm-70mm length) and optional titanium washers. Device used for fixation of large bones, specifically pelvic bones, to address degenerative sacroiliitis and sacroiliac joint disruptions. Surgical technique involves implantation of screws to stabilize joint; updated manual includes instructions for adding autologous graft material to facilitate fusion. Device is used in clinical/surgical settings by physicians. Output is mechanical stabilization of the sacroiliac joint, intended to promote fusion and alleviate patient symptoms.

Clinical Evidence

No clinical data. Bench testing only; modification regarding autologous graft material addition did not require additional mechanical testing to establish substantial equivalence.

Technological Characteristics

Cannulated bone screws and washers; Material: Titanium Alloy (Ti-6Al-4V ELI); Principle: Mechanical fixation/fastener; Dimensions: 6.5mm-12.5mm diameter, 30mm-70mm length; Sterilization: Not specified.

Indications for Use

Indicated for fixation of large bones, including pelvic bones, in patients with degenerative sacroiliitis and sacroiliac joint disruptions.

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 (K102907)

Submission Summary (Full Text)

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K110512

Zyga Technology, Inc. Special 510(k) - SImmetry™ Sacroiliac Joint Fusion System Modification MAR 2 3 20i1 February 21, 2011

Attachment F

# 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 and Clinical<br>Ph. 612.455.1061, ext. 104<br>Fax. [phone] |
| Date of Preparation | February 21, 2011 |

#### 2. General Information

| Trade Name | SImmetryTM Sacroiliac Joint Fusion System |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual<br>Name | Fixation Device/Bone Screw |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Classification | Class II (per 21 CFR § 888.3040) |
| Manufacturer | Zyga Technology, Inc.<br>700 10th Ave South<br>Minneapolis, MN 55415-1745 |
| Identification of<br>Predicate Devices | K102907<br>Zyga Technology, Inc.<br>SImmetryTM Sacroiliac Joint Fusion System |
| Device Description | The SImmetryTM Sacroiliac Joint Fusion System<br>consists of cannulated screws available in titanium<br>having diameters ranging from 6.5mm-12.5mm; and<br>lengths of 30mm-70mm; titanium washers are available<br>for the 6.5mm diameter screws. The revised surgical<br>technique manual for the new modified version of the<br>SImmetry™ Sacroiliac Joint Fusion System contain<br>instructions for adding autologous graft material to the<br>sacroiliac joint to help ensure fusion. |
| Intended Use /<br>Indications for Use | The SImmetry™ Sacroiliac Joint Fusion System is<br>intended for fixation of large bones, including bones of<br>the pelvis, for conditions including degenerative<br>sacroiliitis and sacroiliac joint disruptions. |
| Technological<br>Characteristic | The principle of operation and fundamental scientific<br>technology of the subject devices is identical to that of<br>the identified predicate. |
| Materials | The subject devices are manufactured from Titanium<br>Alloy (Ti-6Al-4V ELI). |
| Technological<br>Comparison | The modification of the SImmetry™ Sacroiliac Joint<br>Fusion System does not represent a change in<br>technological characteristics from that of the indicated<br>predicate device, and therefore does not raise any new<br>questions of safety or effectiveness. |
| Summary of<br>Non-clinical<br>Performance Data | The modification from the previous version of this<br>device does not affect the intended use or alter the<br>fundamental scientific technology or performance of<br>the device when compared to the identified predicate.<br>The addition of autologous graft material to the<br>sacroiliac joint does not require testing to ensure<br>substantial equivalence to the unmodified device. |
| 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<br>composition and mechanical performance when<br>compared to the predicate device cleared under<br>K102907. |

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#### Zyga Technology, Inc. Special 510(k) - SImmetry™ Sacroiliac Joint Fusion System Modification February 21, 2011 ﺳﮯ

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

Zyga Technology, Inc. % Ms. Diane Brinza Director of Regulatory and Clinical 700 10th Avenue South, Suite 400 Minneapolis, Minnesota 55415

MAR 2 3 2011

Re: K110512

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 21, 2011 Received: February 23, 2011

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

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Page 2 - Ms. Diane Brinza

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 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 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/ReportalProblem/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,

Ky B. n h
for

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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Zyga Technology, Inc. Special 510(k) - SImmetry™ Sacroiliac Joint Fusion System Modification February 21, 2011

Attachment >

Indications for Use Statement

| 510(k) Number (if known) | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | SImmetry Sacroiliac Joint Fusion System |
| Indications for Use | The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109) OR

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Over-The-Counter Use_

for M. Melleerson
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110572