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

Device Description

The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm-14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm-14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "SImmetry® Sacroiliac Joint Fusion System." This is a medical device, specifically a smooth or threaded metallic bone fixation fastener, and the submission is a "Special 510(k)." Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modifications do not affect the indications for use or the fundamental scientific technology of the device.

Based on the nature of this submission (a Special 510(k)) and the information provided, no acceptance criteria or studies proving the device meets those criteria are included in the document. The document explicitly states:

"No performance data is required to support this Special 510(k)."
"This Special 510(k) does not involve any changes to the technological characteristics of the device. The principle of operation of the subject device is identical to that of the predicate device cleared under K141549, SImmetry Sacroiliac Joint Fusion System."

Therefore, I cannot provide the requested information. The FDA's clearance for this device (K151818) is based on its substantial equivalence to a previously cleared predicate device (K141549), and not on a new study demonstrating its performance against specific acceptance criteria.

Summary

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

August 5, 2015

Zyga Technology, Incorporated Ms. Diane Brinza Director of Regulatory Affairs 5600 Rowland Road, Suite 200 Minnetonka, Minnesota 55343

Re: K151818

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: July 3, 2015 Received: July 6, 2015

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Diane Brinza

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K151818

Device Name SImmetry® Sacroiliac Joint Fusion System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

[As required by 21 CFR 807.92(c)]

Date of Preparation	July 3, 2015
Submitter' Nameand Address	Zyga Technology, Inc.5600 Rowland Road, Suite 200Minnetonka, MN 55343
Contact Person	Diane BrinzaDirector of Regulatory AffairsPh. 952-698-9959Fax. 952-698-9940dbrinza@zyga.com
Proprietary Name	SImmetry® Sacroiliac Joint Fusion System
Common / UsualName	Sacroiliac Joint FixationBone Screw
Classification	Class II per 21 CFR Part 888.3040Smooth or threaded metallic bone fixation fastenerDivision of Orthopedic Devices
Product Code	OUR
Manufacturer	Zyga Technology, Inc.5600 Rowland Road, Suite 200Minnetonka, MN 55343
Predicate Device	K141549 SImmetry Sacroiliac Joint Fusion System
Device Description	The SImmetry Sacroiliac Joint Fusion System consists ofsterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants designed to transfixthe sacrum and ilium, providing stability for bony fusion.The surgical implants are available in various sizes toaccommodate patient anatomy. Implants have majordiameters ranging from 6.5mm-14.5mm, in 2mmincrements. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mmfor partially threaded implants. All partially threadedimplants and 6.5mm diameter fully threaded implants havea pre-assembled washer. Individually sterile packagedwashers are available for fully threaded implants havingdiameters ranging from 8.5mm-14.5mm.All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
Indication for Use	The SImmetry Sacroiliac Joint Fusion System is intendedfor sacroiliac joint fusion for conditions including sacroiliacioint disruptions and degenerative sacroiliitis.
Performance Data	No performance data is required to support this Special510(k).
Technology	This Special 510(k) does not involve any changes to thetechnological characteristics of the device. The principle ofoperation of the subject device is identical to that of thepredicate device cleared under K141549, SImmetrySacroiliac Joint Fusion System.
SubstantialEquivalenceConclusion	Equivalence for the SImmetry System is based onsimilarities in indications for use, design features,operational principles, and material composition whencompared to the predicate devices cleared under K141549,SImmetry Sacroiliac Joint Fusion System.

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.