SI-Restore Sacroiliac Joint Fixation System

K200868 · Biofusion Medical · OUR · Apr 17, 2020 · Orthopedic

Device Facts

• Record ID: K200868
• Device Name: SI-Restore Sacroiliac Joint Fixation System
• Applicant: Biofusion Medical
• Product Code: OUR · Orthopedic
• Decision Date: Apr 17, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

SI-Restore® Sacroiliac Joint Fixation Screw is a metallic bone fixation device designed to stabilize and fuse the sacroiliac (SI) joint. The device consists of a cannulated, smooth or textured titanium screw with an integrated titanium washer for full cortex engagement. It is implanted by a surgeon using a delivery system that utilizes guide pins for accurate preparation and placement. By preventing motion at the SI joint, the device facilitates fusion, addressing conditions such as joint disruptions and degenerative sacroiliitis. The device is intended for use in a clinical/surgical setting.

Clinical Evidence

No clinical data provided. Performance data was not included in the submission as the design changes did not necessitate additional testing.

Technological Characteristics

Cannulated, smooth or textured screw with washer; Material: Ti 6Al-4V ELI (ASTM F136); Delivery system uses guide pins; Class II metallic bone fixation fastener.

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-Restore® Sacroiliac Joint Fixation System (K182919)

Submission Summary (Full Text)

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April 17, 2020

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Biofusion Medical % Daniel Lanois Consultant SurgOp Support 101 Lamond Ct Prosper, Texas 75078

Re: K200868

Trade/Device Name: SI-Restore® Sacroiliac Joint Fixation 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 30, 2020 Received: April 1, 2020

Dear Daniel Lanois:

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 medical devices and radiation-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, MBE Assistant Director (Acting) 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) K200868

Device Name

SI-Restore® Sacroiliac Joint Fixation Screw

#### Indications for Use (Describe)

The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|-------------------------------------------------|
| [x] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |

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| Date Prepared | April 13, 2020 | | |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------|
| Manufacturer | Biofusion Medical LLC | | |
| Address | 2101 E St Elmo Rd, Building 1, Suite 100, PMB-1, Office 231, Austin, TX 78744 | | |
| Telephone | 866-489-0602 | | |
| Fax | 866-441-5351 | | |
| Contact Person | Daniel Lanois<br>Consultant | | |
| Address | SurgOp Support LLC<br>101 Lamond Ct, Prosper, TX 75078 | | |
| Telephone | 678-371-3605 | | |
| Fax | | | |
| Email | [e-mail] | | |
| Trade Name | SI-Restore® Sacroiliac Joint Fixation Screw | | |
| Common Name | Bone Screw or Internal Fixation Device | | |
| Panel Code | Orthopedic/87 | | |
| Classification Name | Smooth or threaded metallic bone fixation fastener | | |
| Class | Class II | | |
| Regulation Number | 21 CFR 888.3040 | | |
| Product Code | OUR | | |
| Name of Predicate Device | SI-Restore® Sacroiliac Joint<br>Fixation System | 510(k) #<br>K182919 | Manufacturer<br>Biofusion Medical |
| Description | The SI-Restore® Sacroiliac Joint Fixation Screw consists of a cannulated, smooth or textured, titanium (Ti 6Al-4V ELI, per ATSM F136) screw with a titanium (Ti 6Al-4V ELI, per ATSM F136) washer affixed to the head of the screw for full cortex engagement. The implant is designed to prevent motion of the sacroiliac (SI) joint. The delivery system uses guide pins for accurate preparation and placement of the implant. | | |
| Indications and<br>Intended Use | The Biofusion Medical SI-Restore® Sacroiliac Joint Fixation Screw is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. | | |
| Technological<br>Characteristics/<br>Substantial<br>Equivalence | Documentation was provided to demonstrate that the Subject device, is substantially equivalent to the Predicate. The Subject device is substantially equivalent to the Predicate device in intended use, indications for use, materials, technological characteristics, and labeling. | | |
| Performance<br>Data | Performance data is not included in this submission. The design changes being included for review do not present a new worst-case configuration that would require additional performance testing. | | |
| Conclusion | Based on the intended use, indications for use, technological characteristics, materials, and comparison to Predicate devices, the Subject device has been | | |

# 510(k) Summary (as required by 21 CFR 807.92)