IFUSE IMPLANT SYSTEM

K110838 · SI-BONE, Inc. · OUR · Apr 21, 2011 · Orthopedic

Device Facts

• Record ID: K110838
• Device Name: IFUSE IMPLANT SYSTEM
• Applicant: SI-BONE, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Apr 21, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

The iFuse SI Joint Fusion System is a surgical implant system designed for sacroiliac joint fusion. The device consists of metallic (titanium) rods with a porous plasma spray coating. These rods are surgically implanted into the bone to provide fixation. The system includes rods with diameters of 4.0 mm and 7.0 mm and lengths ranging from 30 mm to 70 mm. The device is used by surgeons in a clinical setting to stabilize the sacroiliac joint, thereby addressing conditions such as joint disruptions and degenerative sacroiliitis. The primary benefit to the patient is the achievement of joint fusion through mechanical fixation.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including axial pull-out testing, Finite Element Analysis (FEA), and cadaver testing.

Technological Characteristics

Metallic (titanium) rods with porous plasma spray coating. Diameters: 4.0 mm and 7.0 mm. Lengths: 30 mm to 70 mm. Principle: mechanical bone fixation fastener. Class II device (21 CFR 888.3040).

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

• SI-Bone, Inc's SI Joint Fusion System (K080398; K092375)

Submission Summary (Full Text)

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# KII0838

## 510(k) SUMMARY

## SI-Bone's iFuse SI Fusion System

### Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared

Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103

[phone] Phone: Facsimile: [phone]

> Janice M. Hogan Contact Person:

March 25, 2011 Date Prepared:

### Name of Device and Name/Address of Sponsor

iFuse SI Joint Fusion System

SI-Bone, Inc. 550 South Winchester Blvd., Suite 620, San Jose, CA 95128

Common or Usual Name (Product Code/Definition): Sacroiliac Joint Fixation (OUR/ sacroiliac joint fusion)

Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fixation fastener

## Predicate Devices

SI-Bone, Inc's SI Joint Fusion System (K080398; K092375)

#### Intended Use

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

## Technological Characteristics

The SI Fusion System consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant within the bone to create fixation. The system includes 4.0 mm and 7.0 mm diameter fusion rods, which range in length from 30 mm to 70 mm.

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# KII D838

## Performance Data

Axial pull-out testing, Finite Element Analysis (FEA), and cadaver testing demonstrate that the iFuse is substantially equivalent with respect to fixation of the SI joint.

## Substantial Equivalence

The iFuse has the same intended use, principles of operation, and technological characteristics and similar indications for use as the predicate SI Joint Fusion System. There are no differences in the SI Joint Fusion System's technological characteristics or principles of operation, thus the device does not raise any new questions of safety or effectiveness. Performance data demonstrate that the SI Joint Fusion System is as safe and effective as previously cleared SI Joint Fusion System. Thus, the SI Joint Fusion System is substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The logo is black and white.

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

APR 2 1 2011

SI-Bone, Inc. % Ms. Janice M. Hogan Hogan & Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K110838

Trade/Device Name: SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fastener Regulatory Class: Class II Product Code: OUR Dated: March 25, 2011 Received: March 25, 2011

Dear Ms. Hogan:

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

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Page 2 - Ms. Janice M. Hogan

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/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 Small Manufacturers, International and Consumer Assistance at its toll-frec number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htmi.

Sincerely yours,

Sincerely yours,

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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## Indications for Use Statement

11 0636 510(k) Number (if known):

iFuse SI Joint Fusion System Device Name:

Indications for Use:

The iFuse System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerson

(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K11 0838

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