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 diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850 and K131405.

AI/ML Overview

This document, an FDA 510(k) summary for the iFuse Implant System®, details a premarket notification for a medical device. However, it explicitly states that "No performance testing was required to support the modified labeling that is the subject of this 510(k)." Therefore, the document does not contain information on acceptance criteria or a study proving the device meets said criteria as it pertains to this specific submission.

The 510(k) is for a modification to labeling of an already existing and previously cleared device (iFuse Implant System). The submission focuses on demonstrating substantial equivalence to its predicate device rather than presenting new performance data.

Consequently, I cannot provide the requested information from the provided text, as the study details and acceptance criteria are not present.

Summary

{0}------------------------------------------------

510(k) SUMMARY - iFuse Implant System®

JUL 2 3 2014

510(k) Owner's Name, Address, and Telephone Number SI-BONE, Inc., 3055 Olin Avenue, Suite 2200, San Jose, CA 95128 (408) 207-0700

Contact Person

Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. Email: rdubois@si-bone.com Mobile: 408-828-5019

Office: 408-207-0700 x2236 Facsimile: 408-557-8312

Date Prepared: July 22, 2014

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 and K131405)

Intended Use

Device Description

Technological Characteristics

The iFuse Implant System® consists of a series of metallic (titanium), porous plasma spray 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).

Substantial Equivalence and Conclusion

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.

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

July 23, 2014

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

Re: K141049

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: July 8, 2014 Received: July 9, 2014

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 10 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. Iisting 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

{2}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Aiso, 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K141049

Device Name: SI-BONE iFuse Implant System

Indications for Use:

Prescription Use______________________________________________________________________________________________________________________________________________________________________________	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 SubpartD)		(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Elizabeth L투데ank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.