SI-Cure Sacroiliac Joint Fusion System

K231951 · Alevio, LLC · OUR · Jul 28, 2023 · Orthopedic

Device Facts

• Record ID: K231951
• Device Name: SI-Cure Sacroiliac Joint Fusion System
• Applicant: Alevio, LLC
• Product Code: OUR · Orthopedic
• Decision Date: Jul 28, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint.

Device Story

The SI-Cure Sacroiliac Joint Fusion System is a metallic bone fixation system used by surgeons to stabilize and fuse the sacroiliac joint. The system consists of titanium alloy bone screws (diameters 7mm, 9.5mm, 10.5mm, 11mm) and optional serrated washers for load distribution. The device is implanted during surgical procedures to provide structural support and immobilization of the joint. By securing the joint, the system facilitates fusion, which can alleviate pain and restore stability in patients suffering from joint dysfunction or fractures. The system is intended for use in clinical settings by qualified orthopedic or spinal surgeons.

Clinical Evidence

No clinical data. Bench testing was not required as the modifications (additional headless screw sizes) do not introduce a new worst-case scenario for mechanical performance compared to the cleared predicate system.

Technological Characteristics

Materials: Titanium alloy Ti-6AL-4V ELI per ASTM F136. Components: Bone screws (7mm, 9.5mm, 10.5mm, 11mm diameters) and optional serrated washers. Mechanism: Metallic bone fixation fastener for structural support/immobilization. Sterilization: Not specified (implied standard medical device sterilization).

Indications for Use

Indicated for skeletally mature patients with sacroiliac joint dysfunction due to disruption or degenerative sacroiliitis (including postpartum cases >6 months), patients requiring sacropelvic fixation during lumbar/thoracolumbar fusion, and patients with acute, non-acute, or non-traumatic sacroiliac joint fractures.

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-Cure Sacroiliac Fusion Joint System (K223819)
• Synthes 6.5 mm Cannulated Screws (K021932)

Submission Summary (Full Text)

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July 28, 2023

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Alevio, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K231951

Trade/Device Name: SI-Cure Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: June 30, 2023 Received: June 30, 2023

Dear Nathan Wright:

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,

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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

Submission Number (if known)

K231951

Device Name

SI-Cure Sacroiliac Joint Fusion System

Indications for Use (Describe)

The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint.

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

< Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(K) SUMMARY

| Submitter's Name: | Alevio, LLC |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 200 Cahaba Park Circle<br>Suite 100<br>Birmingham, Alabama 35242 |
| Submitter's Telephone: | 205-783-5778 |
| Contact Person: | Nathan Wright MS, RAC<br>Empirical Technologies<br>719-351-0248<br>[e-mail]<br>Image: Empirical Technologies Logo |
| Date Summary was Prepared: | June 30, 2023 |
| Trade or Proprietary Name: | SI-Cure Sacroiliac Fusion Joint System |
| Device Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification & Regulation #: | Class II per 21 CFR §888.3040 |
| Product Code: | OUR |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The SI-Cure Sacroiliac Joint Fusion System consists of titanium bone screws of Ø7 mm, Ø9.5 mm, Ø10.5 mm, and Ø11 mm diameter and various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw head for load distribution. The screws are made from titanium alloy Ti-6AL-4V ELI per ASTM F136.

The purpose of this submission is to add headless screws with additional screw size options to the previously cleared system.

# INDICATIONS FOR USE

The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

# TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar or the same between the subject and predicates:

- Indications for Use
- Material of Manufacture ●
- . Structural Support Mechanism
- Sizes and Features ●

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- Sterilization ●
- Manufacturing and Biocompatibility
- Mechanical Performance ●

#### Predicate Devices

| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|-------------|----------------------------------------|---------------|----------------|
| K223819 | SI-Cure Sacroiliac Fusion Joint System | Alevio, LLC | Primary |
| K021932 | Synthes 6.5 mm Cannulated Screws | Synthes (USA) | Additional |

### PERFORMANCE DATA

Bench testing was not required in this submission because the addition of the headless screws and length and diameter options do not introduce a new worst case for mechanical performance compared to the cleared implants and do not require performance testing.

## CONCLUSION

The overall technology characteristics and mechanical performance evaluation lead to the conclusion that subject SI-Cure Sacroiliac Fusion Joint System is substantially equivalent to the predicate device.