SILEX SACROILIAC JOINT FUSION SYSTEM

K140079 · X-Spine Systems, Inc. · OUR · Mar 25, 2014 · Orthopedic

Device Facts

• Record ID: K140079
• Device Name: SILEX SACROILIAC JOINT FUSION SYSTEM
• Applicant: X-Spine Systems, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Mar 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Silex Sacroiliac Joint Fusion System consists of titanium alloy bone screws of varying diameters, lengths, and thread configurations. Designed for surgical fusion of the sacroiliac joint. Implants are provided clean and non-sterile; require steam autoclave sterilization by healthcare professionals prior to use. Used by surgeons in clinical settings to stabilize the sacroiliac joint in patients with disruptions or degenerative sacroiliitis. System provides mechanical fixation to facilitate joint fusion, potentially reducing pain and improving stability for the patient.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Titanium alloy (ASTM F136); optional plasma coating of commercially pure titanium (ASTM F1580) on 12.5mm diameter implants. Mechanical bone fixation fasteners. Sterilization via steam autoclave.

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

• Silex Sacroiliac Joint Fusion System (K123702)
• iFuse Implant System (K131405)
• SImmetry Sacroiliac Joint Fusion System (K130092)
• SI-LOK Sacroiliac Joint Fixation System (K112028)
• MSB Sacroiliac Joint Fusion System (K110472)

Submission Summary (Full Text)

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# 510(k) Summary

# mar 2 5 2014

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | X-spine Systems, Inc. |
|-------------------------|-----------------------------------------------------|
| | 452 Alexandersville Rd. |
| | Miamisburg, OH 45342 |
| | Telephone [phone] |
| | FAX [phone] |
| Official Contact: | David Kirschman, M.D. |
| | Chief Medical Officer |
| Date Prepared: | March 18, 2014 |
| DEVICE NAME | |
| Trade/Proprietary Name: | Silex™ Sacroiliac Joint Fusion System |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Description: | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Device Class: | Class II |
| Product Code: | OUR |
| Regulation Number: | §888.3040 |

# ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

# INDICATIONS FOR USE

The Silex Sacroiliac Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

# DEVICE DESCRIPTION

The Silex Sacroiliac Joint Fusion System consists of bone screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The Silex system is manufactured from Titanium alloy in accordance with ASTM F136, and the larger diameter (12.5mm) implants may optionally have the exterior surfaces plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. Silex implants are intended for single use only and should not be reused under any circumstances.

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The implants and associated components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.

The purpose of this submission is to modify the Indications for Use (IFU).

# PREDICATE DEVICES

- . X-spine Systems, Inc. ~ Silex Sacroiliac Joint Fusion System (K123702)
- . SI-Bone, Inc. - iFuse Implant System (K131405)
- Zyga Technology, Inc. SImmetry Sacroillac Joint Fusion System (K130092) .
- Globus Medical, Inc. SI-LOK Sacroiliac Joint Fixation System (K112028) .
- Medtronic Sofamor Danek, Inc. MSB Sacroiliac Joint Fusion System (K110472) .

# EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes. of FDA's regulation of medical devices, the Silex Sacroiliac Joint Fusion is substantially equivalent to predicate devices based on a comparison including the following characteristics:

- · FDA Product Code
- · Indications for Use
- · Surgical Approach
- · Anatomical Region
- . Implant Materials
- . Product Dimensions

# PERFORMANCE DATA

No performance testing was required to support the modifications for Use as there are no changes to the technological characteristics of the device.

In summary, the Silex Sacroiliac Joint Fusion System is substantially equivalent to predicate devices and is capable of performing in accordance with its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 25, 2014

X-Spine Systems. Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K140079

Trade/Device Name: SilexTM 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 10, 2014 Received: February 11, 2014

Dear Dr. Kirschman:

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

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

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# Page 2 - David Kirschman. M.D.

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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/dcfault.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.

# Ronald P. Jean -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

# 510(k) Number (if known)

K140079

#### Device Name

Silex Sacroiliac Joint Fusion System

#### Indications for Use (Describe)

The Silex Sacroiliar Joint Fusion System is intended for sacroilias joint fusion for conditions including secroiliae joint discuptions 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)

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

FOR FDA USE ONLY

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

#### Dmitrie . PhD Division o a ere Devices

FORM FDA 3881 (9/13)

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