iFuse Implant System

K151718 · SI-BONE, Inc. · OUR · Oct 29, 2015 · Orthopedic

Device Facts

• Record ID: K151718
• Device Name: iFuse Implant System
• Applicant: SI-BONE, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Oct 29, 2015
• 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 peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

Device Story

iFuse Implant System consists of porous plasma spray-coated titanium rods (30-90mm length, 4-7mm diameter) used for sacroiliac joint fusion. Implants are placed surgically to provide immediate stabilization and facilitate biological fixation. System includes associated surgical instrumentation. Used by surgeons in clinical settings to treat sacroiliac joint dysfunction. Output is the physical fusion of the joint, intended to reduce pain, improve patient function, and enhance quality of life. Clinical benefit supported by prospective randomized controlled trials and multicenter single-arm studies showing sustained improvements in pain and disability scores at 12 months post-implantation.

Clinical Evidence

Evidence includes prospective and retrospective studies. INSITE (n=148): prospective randomized controlled trial comparing iFuse (n=102) to non-surgical management (n=46); showed significant improvement in pain, disability, and quality of life at 6 and 12 months for the iFuse group. SIFI (n=172): prospective multicenter single-arm trial; showed improvements in pain, disability, and quality of life compared to baseline. Results across both studies were consistent.

Technological Characteristics

Metallic (titanium) rods with porous plasma spray coating. Dimensions: 30-90mm length, 4-7mm diameter. Designed for surgical implantation to achieve biological fixation and stabilization. No changes to technological characteristics in this submission.

Indications for Use

Indicated for patients with sacroiliac joint dysfunction resulting from sacroiliac joint disruption and degenerative sacroiliitis, including cases originating during pregnancy or peripartum period persisting postpartum >6 months.

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 (K080398)
• iFuse Implant System (K092375)
• iFuse Implant System (K110838)
• iFuse Implant System (K122074)
• iFuse Implant System (K123850)
• iFuse Implant System (K131405)
• iFuse Implant System (K141049)
• iFuse Implant System (K150714)
• iFuse Implant System (K150875)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

October 29, 2015

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

SI-BONE, Incorporated Ms. Roxanne Dubois Vice President, Regulatory Affairs and Quality Assurance 3055 Olin Avenue, Suite 2200 San Jose, California 95128

Re: K151718

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: October 1, 2015 Received: October 2, 2015

Dear Ms. Dubois:

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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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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# INDICATIONS FOR USE STATEMENT

K151718 510(k) Number (if known):

Device Name: SI-BONE iFuse Implant System

Indications for 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 peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) SUMMARY - iFuse Implant System®

#### 510(k) Owner's Name, Address, and Telephone Number

SI-BONE, Inc., 3055 Olin Avenue, Suite 2200, San Jose, CA 95128; [phone]

#### Contact Person

Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. Email: [e-mail] Mobile: [phone]; Office: 408-207-0700; Facsimile: 408-557-8312

Date Prepared: October 28, 2015

Trade Name of Device: iFuse Implant System®

Common or Usual Name: Orthopedic Rod

Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR

Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714, K150875)

#### 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 peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.

#### Device Description

The iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714 and K150875.

#### Technological Characteristics

The iFuse Implant System® consists of a series of metallic (titanium), porous plasma sprav coated rods, intended for surgical implant within the bone to create biological fixation, immediate stabilization and fusion. This 510(k) does not involve any changes to the technological characteristics of the device.

#### Performance Data

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

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### Clinical Tests

Data to support claims of improvement in pain, disability and quality of life at 12 months post-implantation come from prospective and retrospective studies. Prospective studies included INSITE (Investigation of Sacroiliac Fusion Treatment) and SIFI (Sacroiliac Joint Fusion with iFuse Implant System). INSITE is a prospective randomized controlled trial of 148 patients with sacroiliac joint dysfunction assigned to either sacroiliac (SI) joint fusion with iFuse Implant System (n=102) or non-surgical management (NSM, n=46, control group). At both 6 and 12 months, INSITE study data showed improvement in SI joint pain, disability due to lower back pain, and quality of life (by two measures) in the iFuse implant group. SIFI is a prospective multicenter single-arm clinical trial of 172 patients. SIFI data showed improvements in SI joint pain, disability due to SI joint pain, and quality of life (by two measures) compared to baseline findings. The improvements in SIFI and INSITE were very similar. Follow-up to 24 months is planned but is not completed for all of the enrolled patients.

### Substantial Equivalence and Conclusion

The iFuse Implant System is substantially equivalent to the predicate device (iFuse Implant System).