SpineNet SSP System

K200170 · Spinenet, LLC · KWQ · Feb 5, 2020 · Orthopedic

Device Facts

• Record ID: K200170
• Device Name: SpineNet SSP System
• Applicant: Spinenet, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

Device Story

Anterior cervical plate and screw system; includes fixed and variable self-tapping screws and one- to four-level plates. Used by surgeons in clinical settings to provide spinal stabilization as an adjunct to fusion. Implants available in various sizes to accommodate patient anatomy. Device provides mechanical fixation to the cervical spine; supports fusion process; aids in treating degenerative, traumatic, or deformity-related spinal conditions. Benefits include stabilization of the spinal column to facilitate bone healing.

Clinical Evidence

Bench testing only. Mechanical testing of worst-case construct performed per ASTM F1717, including static and dynamic compression and static torsion. Results demonstrate performance substantially equivalent to predicate devices.

Technological Characteristics

Implants manufactured from titanium alloy (ASTM F136). System comprises plates (1-4 level) and fixed/variable self-tapping screws. Stabilization via anterior cervical fixation. No software or electronic components.

Indications for Use

Indicated for anterior screw fixation of cervical spine (C2-T1) as adjunct to fusion in patients with degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal stenosis, deformity (kyphosis, lordosis, scoliosis), tumors, pseudarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Zavation Cervical Plate System (K130030)
• Uniplate Anterior Cervical Plate (K042544)
• Cervical Spine Locking Plate (CSLP) (K945700)

Submission Summary (Full Text)

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February 5, 2020

Image /page/0/Picture/1 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

SpineNet LLC % Karen Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026

Re: K200170

Trade/Device Name: SpineNet SSP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 22, 2020 Received: January 23, 2020

Dear Karen Warden:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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,

for

Ronald P. Jean, Ph.D. 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200170

Device Name SpineNet SSP System

Indications for Use (Describe)

The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <table><tr><td><div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |

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## 510(k) Summary

| Date: | 22 January 2020 |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | SpineNet LLC<br>1300 Minnesota Ave., Suite 200<br>Winter Park, FL 32789<br>407.539.2483 |
| Sponsor Contact: | King Floyd, President |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 |
| Trade Name: | SpineNet SSP System |
| Common Name: | Anterior cervical plate system |
| Regulatory Class: | Class II |
| Classification Name,<br>Regulation, Product<br>Code: | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060, KWQ |
| Device Description: | The SpineNet SSP System is an anterior cervical plate and screw system<br>which includes fixed and variable self-tapping screws and one- through four<br>level plates. The implants are available in a variety of sizes to accommodate<br>the individual anatomic and clinical circumstances of each patient. |
| Indications for Use: | The SpineNet SSP System is intended for anterior screw fixation of the<br>cervical spine (C2 to T1). The system is to be used as an adjunct to fusion<br>for the treatment of the following indications: degenerative disc disease<br>(defined as neck pain of discogenic origin with the degeneration of the disc<br>confirmed by history and radiographic studies), spondylolisthesis, trauma<br>(i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis,<br>lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion. |
| Materials: | The SpineNet SSP System implants are manufactured from titanium alloy<br>as described by ASTM F136. |
| Primary Predicate: | Zavation Cervical Plate System (Zavation LLC – K130030) |
| Additional Predicates: | Uniplate Anterior Cervical Plate (DePuy Spine – K042544) and Cervical<br>Spine Locking Plate (CSLP) (Synthes Spine – K945700) |
| Performance Data: | Mechanical testing of the worst case SpineNet SSP System construct was<br>performed according to ASTM F1717 and included static and dynamic<br>compression and static torsion.<br>The mechanical test results demonstrate that the SpineNet SSP System<br>device performance is substantially equivalent to the predicate devices. |
| Technological<br>Characteristics: | The SpineNet SSP System possesses technological characteristics similar<br>to those of the predicate devices. These include basic design, material,<br>method of stabilization and anatomic location. Therefore the fundamental<br>scientific technology of the SpineNet SSP System devices is the same as<br>previously cleared devices. |
| Conclusion: | The SpineNet SSP System possesses similar intended use and<br>technological characteristics as the predicate devices. Therefore the<br>SpineNet SSP System is substantially equivalent for its intended use. |