SI Screw System

K173752 · Zavation Medical Products, LLC · OUR · Mar 16, 2018 · Orthopedic

Device Facts

• Record ID: K173752
• Device Name: SI Screw System
• Applicant: Zavation Medical Products, LLC
• Product Code: OUR · Orthopedic
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SI Screw System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

SI Screw System consists of bone screws with varying lengths and graft hole configurations; designed to accommodate patient anatomy. Manufactured from titanium alloy; provided non-sterile for single-use. Used by surgeons in clinical settings for sacroiliac joint fusion. Device functions as a metallic bone fixation fastener to stabilize the joint. Clinical benefit derived from joint fusion to address disruptions and degenerative sacroiliitis.

Clinical Evidence

Bench testing only. Static and dynamic three-point bending tests (ASTM F1264), torque-to-failure, and axial pullout tests (ASTM F543) were performed. Results demonstrate performance equivalent or superior to the predicate device.

Technological Characteristics

Titanium alloy (ASTM F136). Metallic bone fixation fastener. Single-use, non-sterile. Mechanical testing per ASTM F1264 and ASTM F543.

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

• Medical Designs SAMBA Screw System (K121148)

Submission Summary (Full Text)

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March 16, 2018

Zavation Medical Products, LLC Mr. Milton Phillips Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K173752

Trade/Device Name: SI Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: February 19, 2018 Received: February 20, 2018

Dear Mr. Phillips:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Mr. Milton Phillips

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Ronald P. Jean -S

for 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) K173752

Device Name SI Screw System

Indications for Use (Describe)

The SI Screw System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis.

| 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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# 510K Summary

| Date: | February 19, 2018 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Zavation Medical Products LLC<br>220 Lakeland Parkway<br>Flowood, MS 39232<br>Phone: [phone]<br>Fax: [phone] |
| Contact person: | Milton Phillips |
| Trade name: | SI Screw System |
| Common Name: | Sacroiliac Joint Screw |
| Classification: | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion<br>Regulation Number: 21 CFR 888.3040<br>Regulation Name: Smooth or Threaded Metallic Bone<br>Fixation Fastener<br>Product Code: OUR, HWC<br>Regulatory Class: II |

#### Primary Predicate:

Medical Designs SAMBA Screw System (K121148)

#### Device Description:

The SI Screw System consists of bone screw in various lengths and graft hole configurations to accommodate variations in patient anatomy. The SI Screw System is manufactured from Titanium alloy in accordance with ASTM F136. All implants will be provided non-sterile and are intended for single use only.

## Indications for Use:

The SI Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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#### Technological Characteristics:

The SI Screw System possesses the same technological characteristics, design and principles of operation as the predicate. These include: basic design, material, intended use and indications.

#### Performance Data:

Static and dynamic three-point bending test were performed according to ASTM F1264, torqueto-failure and axial pullout per ASTM F543. The mechanical test results demonstrated the SI Screw System performs as well as or better than the predicate device.

#### Conclusion:

The SI Screw System is substantially equivalent to the predicate devices referenced above and is therefore as safe and effective as the predicate for its intended use.