FORTICO Anterior Cervical Fixation System

K191584 · Camber Spine Technologies, LLC · KWQ · Oct 22, 2019 · Orthopedic

Device Facts

• Record ID: K191584
• Device Name: FORTICO Anterior Cervical Fixation System
• Applicant: Camber Spine Technologies, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Device Story

Cervical plating system consisting of plate and bone screws; includes blocking mechanisms to prevent screw back-out. Used for anterior screw fixation to cervical spine (C2-T1). Implanted by surgeons in clinical settings to stabilize spine in patients with degenerative disc disease, trauma, or deformities. Provides mechanical stabilization to facilitate fusion. Benefits patient by restoring spinal alignment and stability.

Clinical Evidence

Bench testing only. Static and dynamic compression bending and static torsion testing performed per ASTM F1717 to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Cervical plating system; includes plate with screw holes and screw back-out blocking mechanisms. Mechanical testing conducted per ASTM F1717 (static/dynamic compression bending, static torsion).

Indications for Use

Indicated for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities (scoliosis, lordosis), tumor, 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

• Medos International Sárl Uniplate 2 Anterior Cervical Plate System (K132324)
• Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846)
• Medtronic International ZEVO™ Anterior Cervical Plate System (K182885, K141632)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.

Camber Spine Technologies LLC % Barry Sands President ROMIS. Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

October 22, 2019

Re: K191584

Trade/Device Name: FORTICO Anterior Cervical Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: September 17, 2019 Received: September 23, 2019

Dear Mr. Sands:

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,

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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# Indications for Use

510(k) Number (if known) K191584

Device Name FORTICO Anterior Cervical Fixation System

#### Indications for Use (Describe)

The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.

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

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# K191584: 510(k) Sumr

Device Trade Name: FORTICO Anterior Cervical Fixation System

| Manufacturer: | Camber Spine<br>501 Allendale Road<br>King of Prussia, PA 19406 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Rami Hamzey<br>Project Engineer<br>The Institute for Musculoskeletal Science & Education (IMSE)<br>Phone: [phone] |
| Prepared by: | Rami Hamzey |
| Date Prepared: | 16 September 2019 |
| Classifications: | 21 CFR §888.3060, Spinal intervertebral body fixation orthosis |
| Class: | II |
| Product Code: | KWQ |
| Primary Predicate: | Medos International Sárl Uniplate 2 Anterior Cervical Plate System (K132324) |
| Additional Predicate(s): | Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146,<br>K181846),<br>Medtronic International ZEVO™ Anterior Cervical Plate System (K182885,<br>K141632) |

#### Indications for use:

The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.

#### Device Description:

The FORTICO Anterior Cervical Fixation System is a cervical plating system that consists of a cervical plate that includes bone screw holes and blocking mechanisms to prevent screw back-out.

#### Predicate Device(s):

The FORTICO Anterior Cervical Fixation System was demonstrated to be substantially equivalent in design to the Medos International Sárl Uniplate® 2 Anterior Cervical Plate System (K132324), the Globus

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Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846), and Medtronic International's ZEVO™ Anterior Cervical Plate System (K182885, K141632).

## Performance Testing Summary:

Testing performed indicates that the FORTICO Anterior Cervical Fixation System is as mechanically sound as similar devices which are legally marketed for sale in the United States. Testing included static and dynamic compression bending and static torsion of the FORTICO Anterior Cervical Fixation System per ASTM F1717. The results are provided for the appropriate governing body to assess against legally marketed products in the United States with identical indications.

### Substantial Equivalence:

Camber Spine asserts that the subject FORTICO Anterior Cervical Fixation System is substantially equivalent to the Medos International Sárl Uniplate® 2 Anterior Cervical Plate System (K132324), Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846), and the Medtronic International ZEVO™ Anterior Cervical Plate System (K182885, K141632) with respect to indications, design, materials, function, manufacturing, and/or performance.

### Conclusion:

Camber Spine provided ample information to demonstrate that the FORTICO Anterior Cervical Fixation System is substantially equivalent to the Medos International Sárl Uniplate 2 Anterior Cervical Plate System (K132324), Globus Medical Inc. XTEND Anterior Cervical Plate System (K092146, K181846), and the Medtronic International ZEVO™ Anterior Cervical Plate System (K182885, K141632) with respect to indications, design, materials, function, manufacturing, and/or performance.