Integrity-SI TM Fusion System

K161755 · Coorstek Medical · OUR · Dec 14, 2016 · Orthopedic

Device Facts

• Record ID: K161755
• Device Name: Integrity-SI TM Fusion System
• Applicant: Coorstek Medical
• Product Code: OUR · Orthopedic
• Decision Date: Dec 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system is used to provide structural stability in skeletally mature individuals who have developed a clinical need to alleviate chronic pain due to SI joint disruptions and degenerative sacroiliitis.

Device Story

Integrity-SI Fusion System consists of partially and fully threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI) screws; designed for insertion across sacroiliac joint to provide stability for joint arthrodesis. Implants available in 10mm and 12mm diameters with pre-assembled washers for joint compression; optional 6.5mm secondary screws available. Provided sterile; used by surgeons in clinical settings. Device provides structural stability to alleviate chronic pain; mechanical performance verified via torsional strength, insertion/removal torque, pullout force, and static/fatigue bending tests. Cadaveric testing confirms surgical implantation safety.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F543-13e1 (torsional strength, insertion/removal torque, pullout force) and ASTM F2193-14 (static and fatigue bending strength). Cadaveric testing performed to validate surgical technique.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI per ASTM F136); optional hydroxyapatite (HA) coating. Design: Partially/fully threaded, self-tapping cannulated screws (10mm, 12mm, 6.5mm diameters). Features: Pre-assembled washers on 10mm/12mm screws. Sterilization: Provided sterile. Connectivity: None (mechanical implant).

Indications for Use

Indicated for sacroiliac joint fusion in skeletally mature individuals with 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

• Synthes 6.5 mm Cannulated Screw (K021932)
• Zyga Technology SImmetry® Sacroiliac Joint Fusion System (K141549)
• Medtronic Sofamor Danek MSB Sacroiliac Joint Fusion Device (K110472)

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

December 14, 2016

CoorsTek Medical LLC Mr. Steve Brown QA/RA Manager 560 West Golf Course Road Providence, Utah 84332

Re: K161755

Trade/Device Name: Integrity-SI"M 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: November 17, 2016 Received: November 18, 2016

Dear Mr. Steve Brown:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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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/ResourcesforYou/Industry/default.htm. 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

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,

# Mark N. Melkerson -S

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) K161755

Device Name Integrity-SI Fusion System

Indications for Use (Describe)

The Integrity-SI Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "CoorsTek" is written in a stylized font, with the "Coors" part in red and the "TEK" part in black. Below "CoorsTek" is the word "MEDICAL" in smaller, black letters. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.

## Section 4: 510(k) SUMMARY [As required by 21 CFR 807.92 (c)]

## Submitter / Contact Person / Date of Preparation

| Submitter/Sponsor | CoorsTek Medical LLC<br>560 W. Golf Course Rd.<br>Providence, UT 84332<br>Phone: [phone]<br>Fax: [phone] |
|---------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person | Steve Brown |
| Date of preparation | December 9th, 2016 |

### General Information

| Trade Name | Integrity-SI™ Fusion System |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Sacroiliac Joint Fixation - Smooth or threaded metallic bone fixation fastener |
| Classification Name and Number | Sacroiliac Joint Fixation, 888. 3040 |
| Regulatory Class | Class II |
| Device Regulation Panel | Orthopedics |
| Product Code | OUR |
| Manufacturer | CoorsTek Medical LLC<br>560 W. Golf Course Rd.<br>Providence, UT 84332 |
| Identification of Legally<br>Marketed Predicate<br>Devices | Synthes 6.5 mm Cannulated Screw (K021932) Zyga Technology SImmetry® Sacroiliac Joint Fusion System (K141549) Medtronic Sofamor Danek MSB Sacroiliac Joint Fusion Device (K110472) |

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Image /page/4/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "Coors" is in red, and the word "Tek" is in black. The word "Medical" is in smaller black font below the word "Tek".

| Device Description | The Integrity-SITM Fusion System consists of partially and fully<br>threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI per<br>ASTM F136) implants designed to be inserted across sacroiliac<br>joint to provide stability for joint arthrodesis. The surgical implants<br>are available in various sizes to accommodate patient anatomy.<br>The 10mm and 12mm diameter screws are offered in and partially<br>and fully threaded versions in lengths ranging from 40-110mm, in<br>5mm increments. All screw sizes are available in non-coated or<br>hydroxyapatite-coated (HA) versions. The 10mm and 12mm<br>screws also include a pre-assembled washer for improved joint<br>compression. The fully threaded 6.5mm diameter, optional<br>secondary screws are offered from lengths of 30 - 70 mm, in 5mm<br>increments. All implants are provided sterile and are individually<br>packaged. The 6.5 mm screws are not for use without the subject<br>10 mm or 12 mm screws. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The system is used to provide structural stability in skeletally<br>mature individuals who have developed a clinical need to alleviate<br>chronic pain due to SI joint disruptions and degenerative<br>sacroiliitis. |
| Indications for Use | Integrity-SITM Fusion System is intended for sacroiliac joint fusion<br>for conditions including sacroiliac joint disruptions and<br>degenerative sacroilitis. |
| Indications for Use<br>Comparison | The intended use for the subject and predicate devices are the<br>same. The indications for use statement for the subject device<br>and the Zyga Technology Simmetry (K021932) and Medtronic<br>Sofamor Danek MSB Sacroiliac Joint Fusion Device (K110472)<br>predicates are identical. The Synthes 6.5 mm Cannulated Screw<br>(K021932) indications for use statement is broader than the<br>subject device but does include SI joint disruptions. |

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Image /page/5/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "CoorsTek" is written in a stylized font, with the "Coors" in red and the "Tek" in black. Below the word "CoorsTek" is the word "Medical" in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's website and marketing materials.

| Summary of Non-Clinical<br>Performance Data | Testing was performed for the Integrity-SI™ Fusion System and<br>demonstrated substantially equivalent performance to the<br>identified predicates. The following mechanical tests were<br>performed: Torsional strength/breaking angle (ASTM F543-13e1) Insertion/removal torque (ASTM F543-13e1) Pullout force (ASTM F543-13e1) Static Bending Strength (ASTM F2193-14) Fatigue Bending Strength (ASTM F2193-14) Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique. |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics<br>Comparison | The technological characteristics and intended use of the subject devices is identical to that of the predicate devices cleared under the following submissions: K141559 Slmmetry Sacroiliac Joint Fusion System K110472 Medtronic Sacroiliac Fusion Device K021932 Synthes 6.5mm Cannulated Screw Both subject and predicate devices include titanium alloy bone screws that are inserted across the SI joint to provide a stable construct to promote arthrodesis across the joint. As a result, the subject device does not introduce any new concerns of safety or effectiveness. |
| Conclusion | Based upon a comparison of the design features, indications for use, technological characteristics, the use of established well known materials, and mechanical performance, the Integrity-SI™ Fusion System has demonstrated substantial equivalence to the identified predicate device systems. The performance data demonstrates that the devices included in the Integrity-SI™ Fusion System do not raise any new questions of safety or effectiveness. |