SI-BONE iFuse Implant System

K150714 · SI-BONE, Inc. · OUR · Apr 17, 2015 · Orthopedic

Device Facts

• Record ID: K150714
• Device Name: SI-BONE iFuse Implant System
• Applicant: SI-BONE, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Apr 17, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

The iFuse Implant System consists of porous plasma spray coated titanium implants (30-90mm length, 4-7mm diameter) and associated surgical instruments. Used for sacroiliac joint fusion in patients with joint dysfunction, disruptions, or degenerative sacroiliitis. The system is implanted by a surgeon using specialized instrumentation to stabilize the joint. The device functions as a metallic bone fixation fastener. This specific submission introduces manual instruments to supplement the existing removal adapter for implant removal. The system maintains the same technological characteristics and intended use as previously cleared SI-BONE iFuse systems.

Clinical Evidence

No clinical data or performance testing was required for this Special 510(k) submission.

Technological Characteristics

Porous plasma spray coated titanium implants; dimensions 30-90mm length, 4-7mm diameter; manual surgical instrumentation; metallic bone fixation fastener; Class II device.

Indications for Use

Indicated for patients requiring sacroiliac joint fusion due to sacroiliac joint dysfunction resulting from 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

• SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049)

Submission Summary (Full Text)

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

April 17, 2015

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

Re: K150714

Trade/Device Name: SI-BONE 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: March 17, 2015 Received: March 19, 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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Page 2 - Ms. Roxanne Dubois

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 vours.

## Lori A. Wiggins -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): K150714

Device Name: SI-BONE iFuse Implant System

Indications for Use:

The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

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 Vice President, Regulatory Affairs & Quality SI-BONE iFuse Implant System [e-mail] 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 408-207-0700 x2236 Office 408-828-5019 Mobile [phone] Fax

Date Prepared: March 17, 2015

Trade Name of Device: iFuse Implant System®, including iFuse Surgical Instruments

Common or Usual Name: Orthopedic Rod and Surgical Instruments

#### Classification Name:

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

Product Code: OUR

# Predicate Devices:

SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049).

#### Intended Use

The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

#### 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

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diameter of 4-7mm. Surgical treatment is accomplished using instrumentation similar to that previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049.

## Technological Characteristics

This 510(k) does not involve any changes to the technological characteristics of the removal system since the predicate devices are also used to remove an implant. The proposed Removal System manual instruments supplement the existing Removal Adapter.

## Performance Data

No performance data is required to support this Special 510(k).

## Substantial Equivalence

The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, the iFuse Implant System is substantially equivalent to the predicate device.

## Conclusions

The iFuse Implant System, including iFuse Surgical Instruments, is substantially equivalent to the predicate device.