PreView-III™ Anterior Cervical Plate System

K223627 · Nexus Spine, LLC · KWQ · Feb 2, 2023 · Orthopedic

Device Facts

• Record ID: K223627
• Device Name: PreView-III™ Anterior Cervical Plate System
• Applicant: Nexus Spine, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PreView-III™ Anterior Cervical Plate System is intended for the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). PreView-III™ Anterior Cervical Plate System is intended for use under 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 (i.e., fracture), tumor, deformity (i.e., kyphosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.

Device Story

The PreView-III™ Anterior Cervical Plate System is a spinal fixation orthosis used to immobilize the cervical spine during fusion procedures. The system consists of metal plates with preassembled locking rings and bone screws. It is implanted by a surgeon via an anterior approach to the cervical spine (C2-T1). The device provides structural stabilization to facilitate bone graft healing. It is intended for use in clinical settings by trained orthopedic or neurosurgeons. The system is designed to treat various spinal pathologies, including degenerative disc disease, trauma, and deformity, ultimately aiming to reduce pain and restore spinal stability for the patient.

Clinical Evidence

Bench testing only. Mechanical performance testing was conducted per ASTM F1717, including static compression bending, static torsion, and dynamic compression bending. Results demonstrated mechanical performance substantially equivalent to the predicate device.

Technological Characteristics

System components include plates with preassembled locking rings and bone screws. All components are manufactured from Ti-6Al-4V ELI (ASTM F-136). The device functions as a spinal intervertebral body fixation orthosis. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring cervical spine fusion (C2-T1) using autogenous/allogenic bone graft. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture), tumor, deformity (kyphosis, scoliosis), spinal stenosis, pseudoarthrosis, and 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

• PreView Anterior Cervical Plate System, Alphaspine, Inc (K062371)

Submission Summary (Full Text)

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February 2, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG".

Nexus Spine, LLC % Ms. Christine Scifert Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112

Re: K223627

Trade/Device Name: PreView-III™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 1, 2022 Received: December 5, 2022

Dear Ms. Scifert:

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,

Colin O'neill -S

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)

#### K223627

Device Name PreView-III™ Anterior Cervical Plate System

#### Indications for Use (Describe)

The PreView-III™ Anterior Cervical Plate System is intended for the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). PreView-III™ Anterior Cervical Plate System is intended for use under 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 (i.e., fracture), tumor, deformity (i.e., kyphosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.

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

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

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#### 510(k) Summary

PreView-III™ Anterior Cervical Plate System January 31, 2023

| Company: | Nexus Spine, LLC<br>2825 East Cottonwood Parkway Suite 330<br>Salt Lake City, UT 84121 |
|--------------------|----------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert<br>Partner, MRC Global<br>Phone: [phone]<br>Email: [e-mail] |
| Trade Name: | PreView-III™ Anterior Cervical Plate System |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Panel: | Orthopedic |
| Product Code: | KWQ |
| Primary Predicate: | K062371 PreView Anterior Cervical Plate System, Alphaspine, Inc |

### Device Description:

The PreView III™ Anterior Cervical Plate System is composed of the following components:

- Plates with preassembled locking rings
- . Bone screws

These components can be assembled by associated instruments to provide immobilization of the cervical spine. All components made from Ti-6Al-4V ELI (ASTM F-136).

## Indications for Use:

The PreView III™ Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1). The PreView III™ Anterior

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Cervical Plate System is intended for use under 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 (i.e., fracture), tumor, deformity (i.e., kyphosis, lordosis, and scoliosis), spinal stenosis, pseudoarthrosis, and failed previous fusion.

## Substantial Equivalence:

The subject components are substantially equivalent to the following predicate device:

- PreView Anterior Cervical Plate System, Alphaspine, Inc (K062371)
The subject components are substantially equivalent to the primary predicate device listed above in terms of intended use, materials of construction, principles of operation, and general design.

## Performance Testing:

The following mechanical performance tests were conducted per ASTM F1717:

- . Static Compression Bending
- Static Torsion
- Dynamic Compression Bending

The results demonstrated that the subject device has substantially equivalent mechanical performance to predicate device.

## Conclusion:

The data presented in this submission demonstrates that the subject PreView III™ Anterior Cervical Plate System is substantially equivalent to the predicate, Alphaspine, Inc, PreView Anterior Cervical Plate System (K062371).