SI-TECHNOLOGY® SI-DESIS® SCREWS

K151462 · Si-Technology, LLC · OUR · Aug 12, 2015 · Orthopedic

Device Facts

• Record ID: K151462
• Device Name: SI-TECHNOLOGY® SI-DESIS® SCREWS
• Applicant: Si-Technology, LLC
• Product Code: OUR · Orthopedic
• Decision Date: Aug 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SI-TECHNOLOGY Device is intended for sacroiliac joint fusion for conditions including sacroillac (SI) joint disruptions and degenerative sacroiliitis.

Device Story

SI-DESIS Screws are metallic bone fixation fasteners designed for sacroiliac joint fusion. System consists of 6.5 mm diameter cannulated screws (partially or fully threaded) and optional 5 mm supplemental screws for fixation of pelvic bones. Used by surgeons in clinical settings to provide stabilization and assist healing of sacroiliac joints. Screws are not intended to replace normal body structures. Device provides mechanical fixation to facilitate fusion; clinical benefit derived from stabilization of joint disruptions and degenerative conditions.

Clinical Evidence

Bench testing only. Performance demonstrated via ASTM F543 (screw strength) and ASTM F2193 (static and fatigue testing). Results indicate performance meets or exceeds predicate devices.

Technological Characteristics

Metallic bone fixation fasteners manufactured from titanium alloy per ASTM F136. Features 6.5 mm diameter cannulated screws and 5 mm supplemental screws. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for sacroiliac joint fusion in patients with sacroiliac joint disruptions and 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

• Globus SI-LOK Sacroiliac Joint Fixation System (K112028)
• Synthes 6.5 mm Cannulated Screw (K021932)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

August 12, 2015

SI-TECHNOLOGY, LLC % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K151462

Trade/Device Name: SI-TECHNOLOGY® SI-DESIS® Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: May 22, 2015 Received: June 1, 2015

Dear Dr. Braddon:

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

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Page 2 – Dr. Linda Braddon

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Mark N. Melkerson -S

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

Enclosure

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Image /page/2/Picture/0 description: The image shows a logo with the letters 'si' in black on the left and the word 'DESIS' in gray on the right. The 'si' is stylized with a curved design, and the 'DESIS' is in a simple sans-serif font. The logo has a modern and minimalist look.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

## Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

## Indications for Use

510(k) Number (if known) K151462

Device Name

SI-TECHNOLOGY® SI-DESIS® Screws

Indications for Use (Describe)

The SI-TECHNOLOGY Device is intended for sacroiliac joint fusion for conditions including sacroillac (SI) joint disruptions and degenerative sacroiliitis.

Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Services(301)443-6740 EF

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In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the SI-TECHNOLOGY® SI-DESIS® Screws is provided below.

| Date Summary Prepared | July 30, 2015 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | SI-TECHNOLOGY, LLC<br>320 East Vine Drive, Suite 217<br>Fort Collins, Colorado 80524<br>Phone: [phone] |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>[e-mail] |
| Trade Name | SI-TECHNOLOGY® SI-DESIS® Screws |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Code -Classification | OUR, HWC<br>21 CFR 888.3040 : Class II |
| Predicate Devices | K112028 – Globus SI-LOK Sacroiliac Joint Fixation System<br>K021932 - Synthes 6.5 mm Cannulated Screw |
| Device Description | The SI-TECHNOLOGY® SI-DESIS® Sacroiliac Joint Fusion Screw System<br>consists of screws designed to assist in the healing of sacroiliac joints for<br>fusion by providing fixation of large bones and large bone fragments of<br>the pelvis. The screws are <b>not</b> intended to replace normal body<br>structures. The screws are offered in 6.5 mm diameter cannulated,<br>partially threaded or fully threaded configurations in various lengths.<br>Additionally, optional supplemental 5 mm diameter screws are offered<br>in various lengths and are to be used <b>only</b> in conjunction with the 6.5<br>mm screws for supplemental screw fixation to accommodate patient<br>anatomy. The screws are manufactured from titanium alloy per ASTM<br>F136. |
| Indications for Use | The SI-TECHNOLOGY® SI-DESIS® Device is intended for sacroiliac joint<br>fusion for conditions including sacroiliac (SI) joint disruptions and<br>degenerative sacroiliitis. |
| Technological Characteristics | As was established in this submission, the subject SI-TECHNOLOGY® SI-<br>DESIS® Screws are substantially equivalent to other predicate devices<br>cleared by the FDA for commercial distribution in the United States. The<br>subject device was shown to be substantially equivalent and has the same<br>technological characteristics to its predicate devices through comparison<br>in areas including design, intended use, material composition, function,<br>and range of sizes. |

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| Non-Clinical Performance Testing<br>Conclusion | Non-clinical testing was performed to demonstrate the SI-TECHNOLOGY® SI-DESIS® Screw System is substantially equivalent to other predicate devices. In order to demonstrate the substantial equivalence, the following tests were performed:<br>Screw strength via ASTM F543 Static and Fatigue testing via ASTM F2193 The results of these studies show the subject SI-TECHNOLOGY® SI-DESIS® Screws meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence<br>Summary (Conclusion) | Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject SI-TECHNOLOGY® SI-DESIS® Screws has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use. |