iFuse TORQ® Implant System

K222605 · SI-BONE, Inc. · OUR · Sep 29, 2022 · Orthopedic

Device Facts

• Record ID: K222605
• Device Name: iFuse TORQ® Implant System
• Applicant: SI-BONE, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Sep 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for: · Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. · Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelyic fixation as part of a lumbar or thoracolumbar fusion. The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures. The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

Device Story

iFuse TORQ Implant System comprises threaded, fenestrated, cannulated, 3D-printed titanium alloy implants and associated surgical instruments; includes optional washers for poor bone quality. Implants allow packing of autograft/allograft materials. Used in clinical settings by surgeons for sacroiliac joint fusion and pelvic fracture fixation. Navigation instruments integrate with Medtronic StealthStation to assist surgeons in locating anatomical structures via stereotactic guidance using CT, MR, or fluoroscopic images. System provides mechanical stabilization of the sacroiliac joint or pelvic fractures; aids in precise implant placement during surgery. Benefits include improved joint stability and fixation for patients with dysfunction or fractures.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Implants constructed from Ti-6Al-4V ELI titanium alloy (ASTM F3001). Features: threaded, fenestrated, cannulated, 3D-printed design. Compatible with 3.2 mm guidewires. Navigation instruments interface with Medtronic StealthStation for stereotactic guidance.

Indications for Use

Indicated for sacroiliac joint fusion in patients with sacroiliac joint dysfunction (disruption, degenerative sacroiliitis) and for augmenting immobilization in skeletally mature patients undergoing sacropelvic fixation during lumbar/thoracolumbar fusion. Also indicated for pelvic fracture fixation (acute, non-acute, nontraumatic). Navigation instruments indicated for use with Medtronic StealthStation for stereotactic surgery.

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 TORQ Implant System (K213667)
• iFuse TORQ Implant System (K203247)
• iFuse-3D Implant System (K190230)
• iFuse-3D Implant System (K182983)
• iFuse-3D Implant System (K172268)

Submission Summary (Full Text)

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September 29, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

SI-BONE, Inc. Meirav Harsat Director, Regulatory Affairs 471 El Camino Real Suite 101 Santa Clara, California 95050

Re: K222605

Trade/Device Name: iFuse TORO® Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC, OLO Dated: August 26, 2022 Received: August 29, 2022

Dear Meirav Harsat:

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/cdrh/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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K22605

Device Name iFuse TORQ® Implant System

## Indications for Use (Describe)

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:

· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.

· Augmenting immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelyic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and nontraumatic fractures.

The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| | <span> <span style="font-size: 1em;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--|----------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 1em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) SUMMARY - iFuse TORQ® Implant System

#### I. SUBMITTER

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

Contact Person: Meirav Harsat, Director of Regulatory Affairs, SI-BONE, Inc. Email: mharsat(@si-bone.com Phone: [phone] Date Prepared: August 30, 2022

#### II. DEVICE

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

#### III. PREDICATE AND REFERENCE DEVICES

| Primary Predicate: | iFuse TORQ Implant System K213667 |
|------------------------|-----------------------------------------------------------------------------------------|
| Additional Predicates: | iFuse TORQ Implant System K203247<br>iFuse-3D Implant System, K190230, K182983, K172268 |

#### IV. DEVICE DESCRIPTION

The iFuse TORQ Implant System consists of the iFuse-TORQ Implants and associated Instruments. consists of threaded, fenestrated, cannulated, 3D-printed implants and associated instruments. Implants are constructed from medical grade titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The implants are fully threaded or with a lag design and provided with optional washers. The washers are intended to add additional support under the head of the screw in situations where the bone quality is poor. The cannulated implants are compatible with off-theshelf 3.2 mm guidewires. The implants, available in various lengths and diameters, allow for packing of autograft and allograft materials.

### V. INDICATIONS FOR USE

The iFuse TORQ Implant System is indicated for sacroiliac joint fusion for:

- . Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

The iFuse TORQ Implant System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.

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The iFuse TORQ Navigation instruments are intended to be used with the iFuse TORQ Implant System to assist the surgeon in precisely locating anatomical structures in iFuse TORQ Implant System procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. iFuse TORO Navigation instruments are intended to be used with the Medtronic StealthStation System.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device has identical technological characteristics compared to the primary predicate device and similar technological characteristics compared to the additional predicate. Risk analyses confirm that the differences do not raise different questions of safety and effectiveness.

#### VII. PERFORMANCE DATA

An assessment of applicable performance data demonstrated that the subject device and its predicates are substantially equivalent.

#### VIII. CONCLUSIONS

The subject device has been shown to be substantially equivalent to the primary and additional predicate devices. The proposed subject device has the same intended use as the predicates and an indication for use that is similar to the predicate devices. The differences in the indications for use do not affect the safety and effectiveness of the device and do not alter the intended therapeutic, diagnostic, prosthetic, or surgical use of the device. The proposed device has identical technological characteristics to the primary predicate and similar technological characteristics to the additional predicate. The differences in the technological characteristics between the subject device and the additional predicate do not raise different questions of safety and effectiveness.