Xenco Medical Multilevel CerviKit

K213456 · Xenco Medical, LLC · KWQ · Dec 21, 2021 · Orthopedic

Device Facts

• Record ID: K213456
• Device Name: Xenco Medical Multilevel CerviKit
• Applicant: Xenco Medical, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

Device Story

Anterior cervical plate system for spinal fixation; attaches to vertebral bodies via bone screws using anterior surgical approach. Features graft windows for intraoperative visualization and bone graft fixation. Available in multiple lengths for multilevel fixation; includes fixed or variable bone screws. Used by surgeons in clinical/OR settings to provide temporary stabilization during cervical spinal fusion. Benefits patients by maintaining alignment and stability during bone healing process.

Clinical Evidence

No clinical data. Bench testing only: static/dynamic compression and static torsion testing per ASTM F1717, and screw push-out testing.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Anterior cervical plate with graft windows. Fixed or variable bone screws. Mechanical performance validated via ASTM F1717. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring temporary anterior cervical spine stabilization (C2-T1) as an adjunct to fusion. Conditions: degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, failed previous fusions, spinal stenosis.

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

• Astura Medical ZION Anterior Cervical Fixation System (K160702)
• Biomet C-TekV MaxAnrm Anterior Cervical Plate (K080646)

Reference Devices

• Xenco Medical Cervical Interbody System (K160313)
• Xenco Medical Sorrento Bone Graft Substitute (K191074)

Submission Summary (Full Text)

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December 21, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Xenco Medical, LLC % Linda Braddon, PhD President / CEO Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock. Georgia 30188

Re: K213456

Trade/Device Name: Xenco Medical Multilevel CerviKit Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 25, 2021 Received: October 26, 2021

Dear Dr. Braddon:

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,

for

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

510(k) Number (if known)

#### K213456

Device Name Xenco Medical Multilevel CerviKit

#### Indications for Use (Describe)

The Xenco Medical Multilevel CerviKit is interior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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Image /page/3/Picture/0 description: The image is a logo for Xenco Medical. The logo is a green hexagon with the letters "Xm" in white. The word "Xenco" is stacked on top of the word "Medical". The hexagon is made up of smaller triangles of different shades of green.

## 510(k) Summary: Xenco Medical Multilevel CerviKit

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

| Date Prepared | December 20, 2021 |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Xenco Medical, LLC<br>9930 Mesa Rim Rd<br>San Diego, CA 92121<br>858-202-1505<br>email: [e-mail] |
| Contact | Secure BioMed Evaluations<br>7828 Hickory Flat Hwy, Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>Contact: Linda Braddon<br>e-mail: [e-mail] |
| Trade Name | Xenco Medical Multilevel CerviKit |
| Common Name | Anterior Cervical Plate |
| Classification Name | Spinal intervertebral body fixation orthosis |
| Class | II |
| Product Code | KWQ |
| CFR Section | 21 CFR section 888.3060 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | K160702 Astura Medical ZION Anterior Cervical Fixation System |
| Additional Predicate<br>Device | K080646 Biomet C-TekV MaxAnrm Anterior Cervical Plate |
| Reference Devices | K160313 Xenco Medical Cervical Interbody System<br>K191074 Xenco Medical Sorrento Bone Graft Substitute |
| Device Description | The Xenco Medical Multilevel CerviKit is intended for anterior screw<br>fixation of the plate to the cervical spine. The fixation construct consists<br>of a cervical plate that is attached to the vertebral body of the cervical<br>spine with bone screws using an anterior approach. Plates are available<br>in a variety of lengths addressing multiple levels of fixation. The Xenco<br>Medical Multilevel CerviKit plate incorporates graft windows on the<br>longitudinal center line for intraoperative visualization and for screw<br>fixation of bone graft. Fixed or variable bone screws are available in two<br>diameters and a variety of lengths. |
| Materials | Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Xenco Medical Multilevel CerviKit is substantially equivalent to the<br>predicate devices in terms of intended use, design, materials used, and<br>mechanical performance. |
| Indications for Use | The Xenco Medical Multilevel CerviKit is intended for anterior screw<br>fixation to the cervical spine. It is to be used in skeletally mature patients<br>as an adjunct to fusion of the cervical spine (C2 to T1). The system is<br>indicated for use in the temporary stabilization of the anterior spine during<br>the development of cervical spinal fusions in patients with: 1) degenerative<br>disc disease (as defined by neck pain of discogenic origin with<br>degeneration of the disc confirmed by patient history and radiographic<br>studies), 2) spondylolisthesis, 3) trauma (including fractures or<br>dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or<br>scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal<br>stenosis. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>• Static and dynamic compression testing per ASTM F1717<br>• Static torsion testing per ASTM F1717<br>• Push-out testing for screws<br>The results of these evaluations indicate that the Xenco Medical Multilevel<br>CerviKit is equivalent to the predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: Non-<br>clinical and Clinical | Xenco Medical considers the Multilevel CerviKit to be substantially<br>equivalent to the predicate devices listed above. This conclusion is<br>based upon the devices' similarities in principles of operation,<br>technology, materials, and indications for use. |

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Image /page/4/Picture/0 description: The image is a logo for Xenco Medical. The logo is a green hexagon with the text "Xenco Medical" written in white. The "X" is larger than the rest of the text. The hexagon is made up of smaller triangles of varying shades of green.