iFuse Implant System®

K190230 · SI-BONE, Inc. · OUR · Apr 3, 2019 · Orthopedic

Device Facts

• Record ID: K190230
• Device Name: iFuse Implant System®
• Applicant: SI-BONE, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Apr 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months. The iFuse Implant System is also intended for sacroliac fusion to augment immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar fusion.

Device Story

iFuse Implant System consists of cannulated, triangular, porous-surfaced titanium implants and associated surgical instruments. Used for sacroiliac joint fusion and stabilization. Principle of operation: triangular geometry and porous surface minimize joint motion/micromotion; interference fit provides fixation and stabilization. Delivered via guide pins for permanent surgical placement. Used by surgeons in clinical settings for minimally invasive sacroiliac joint surgery. Benefits include joint stabilization and fusion for patients with sacroiliac joint dysfunction or those requiring sacropelvic fixation.

Clinical Evidence

No clinical data provided; bench testing only (not applicable as no new performance testing was required for this labeling modification).

Technological Characteristics

Cannulated, triangular-shaped implants made of titanium with a porous surface. Provided sterile via gamma sterilization. System includes guide pins for surgical placement. No changes to technological characteristics compared to predicate.

Indications for Use

Indicated for sacroiliac fusion in skeletally mature patients with sacroiliac joint dysfunction due to joint disruption or degenerative sacroiliitis, including postpartum cases persisting >6 months, and for sacropelvic fixation augmentation during lumbar/thoracolumbar fusion.

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

• iFuse Implant System (K182983)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 3, 2019

SI-BONE, Inc. % Cindy Domecus, R.A.C. Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010

Re: K190230

Trade/Device Name: iFuse Implant 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 5, 2019 Received: February 6, 2019

Dear Ms. Domecus:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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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# Indications for Use

510(k) Number (if known)

### K190230

Device Name iFuse Implant System

Indications for Use (Describe)

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

The iFuse Implant System is also intended for sacroliac fusion to augment immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar fusion.

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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Image /page/3/Picture/1 description: The image shows the logo for SI-BONE iFuse Implant System. The logo is divided into two parts, with "SI-BONE" on the left and "iFuse Implant System" on the right. The text "Minimally Invasive Sacroiliac Joint Surgery" is written below the "iFuse Implant System" text. The SI-BONE logo has a green curved line that goes through the word bone.

# 510(k) SUMMARY - iFuse Implant System®

#### I. 510(k) OWNER

SI-BONE, Inc. 471 El Camino Real, Suite 101, Santa Clara, CA 95050 Phone: [phone]; Fax: [phone]

Contact Person: Cindy Domecus Email: [e-mail] [phone] (office), [phone] (cell) Date Prepared: February 5, 2019

#### II. DATE SUMMARY PREPARED: February 5, 2019

#### III. DEVICE

| Trade Name of Device: | iFuse Implant System® |
|-----------------------|-------------------------------------------------------------|
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Regulation Number: | 21 CFR 888.3040, Smooth or threaded metallic bone fastener. |
| Product Code: | OUR |

#### IV. PREDICATE DEVICE

iFuse Implant System® by SI-BONE, Inc., K182983 (Primary Predicate)

#### V. DEVICE DESCRIPTION

The iFuse Implant System® consists of cannulated triangular, titanium implants1 with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).

#### VI. INDICATIONS FOR USE

The Indications for Use are as follows:

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

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K190230 - Page 2 of 2

Image /page/4/Picture/1 description: The image shows the logo for SI-BONE, a medical device company. The logo features the company name in bold, black letters, with a green arc above the "O" in "BONE." To the right of the company name is the text "iFuse Implant System" in black, followed by the tagline "Minimally Invasive Sacroiliac Joint Surgery" in a smaller font. The logo is clean and professional, conveying a sense of innovation and expertise in the field of orthopedic surgery.

The iFuse Implant System is also intended for sacroiliac fusion to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

# VII. TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE

There are no changes to the technological characteristics of the device that are the subject of this 510(k). Compared to the predicate device, the change to the Indications for Use adds a second paragraph. This addition does not represent a new intended use, as the device is still being used for fusion of the sacroiliac joint.

# VIII. PERFORMANCE DATA

No performance testing was required to support the modified labeling that is the subject of this 510(k).

#### CONCLUSIONS IX.

The intended use and the technological characteristics are unchanged compared to the predicate device, so the subject device is substantially equivalent to the predicate device.