EMERGE Anterior Cervical Plate System

K220275 · Evolution Spine · KWQ · Mar 18, 2022 · Orthopedic

Device Facts

• Record ID: K220275
• Device Name: EMERGE Anterior Cervical Plate System
• Applicant: Evolution Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

The EMERGE™ Anterior Cervical Plate System is a spinal fixation device consisting of titanium alloy (Ti-6Al-4V ELI) plates and fixed-angle bone screws. It is used by surgeons in an operating room setting to provide stabilization of the cervical spine (C2-C7) during fusion procedures. The device is implanted anteriorly to the vertebral body to address conditions such as degenerative disc disease, trauma, tumors, and deformity. By providing rigid fixation, the system supports the stabilization of the spinal segments, facilitating fusion and potentially reducing patient pain and neurological symptoms associated with spinal instability.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including static compression, static torsion, and dynamic compression testing performed in accordance with ASTM F1717 and the FDA guidance document 'Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway'.

Technological Characteristics

Materials: Titanium Alloy (Ti-6Al-4V ELI). Components: Cervical plates and fixed-angle bone screws. Mechanical testing: ASTM F1717 (static compression, static torsion, dynamic compression).

Indications for Use

Indicated for anterior screw fixation to the cervical spine (C2-C7) in patients with degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, spondylolisthesis, or spinal stenosis. Not for posterior element fixation.

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

• EMERGE™ Anterior Cervical Plate System (K212405)
• Atlas Spine V3 Segmental Plating System (K182418)

Submission Summary (Full Text)

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March 18, 2022

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 & Human Services logo. To the right of that 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 that.

Evolution Spine % Todd Wallenstein VP Regulatory/Quality Evolution Spine 2300 N Haskell Ave Dallas. Texas 75204

Re: K220275

Trade/Device Name: Emerge 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 20, 2021 Received: February 3, 2022

Dear Todd Wallenstein:

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, 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) K220275

Device Name EMERGE™ Anterior Cervical Plate System

#### Indications for Use (Describe)

The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> 区 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

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

| Company: | Evolution Spine<br>2300 N Haskell Rd<br>Dallas, TX 75204 |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Todd Wallenstein<br>Evolution Spine<br>2300 N Haskell Ave<br>Dallas, TX 75204<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | March 16, 2022 |
| Device Trade Name:<br>Common Name:<br>Classification:<br>Class:<br>Product Code: | EMERGE™ Anterior Cervical Plate System<br>Spinal Plating System<br>21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis<br>II<br>KWQ, Appliance, Fixation, Spinal Intervertebral Body |
| Primary Predicate:<br>Additional Predicate: | EMERGE™ Anterior Cervical Plate System (K212405)<br>Atlas Spine V3 Segmental Plating System (K182418) |

# Device Description:

The EMERGE™ Anterior Cervical Plate System consists of cervical plates offered in various sizes to accommodate surgical needs and anatomic requirements. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The plates can be used with fixed angle screws. The system is comprised of a Titanium Alloy (Ti-6Al-4V ELI) plates and bone screws. The subject 510(k) adds additional 3-screw plates to the system.

# Indications For Use:

The EMERGE™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors (primary and metastatic), deformity (kyphosis, lordosis or scoliosis), failed previous fusions (pseudarthrosis), spondylolisthesis, and spinal stenosis. The EMERGE™ Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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# Substantial Equivalence:

The subject EMERGE™ Anterior Cervical Plate System possesses the same technological characteristics as the predicate devices. These include:

- Same Intended Use,
- Same Product Code, Class, and Classification, ●
- . Design features,
- Material,
- Anatomic location,
- Mechanical performance,
- Dimensional attributes.

Therefore, the fundamental scientific technology of the EMERGE™ Anterior Cervical Plate System devices is the same as previously cleared devices.

# Performance Data:

Testing on the EMERGE™ Anterior Cervical Plate System included static compression, static torsion, and dynamic compression per ASTM F1717. The results demonstrate that the EMERGE™ Anterior Cervical Plate is substantially equivalent to the performance criteria identified in Spinal Plating Systems -Performance Criteria for Safety and Performance Based Pathway Guidance document; FDA-2019-D-1647.

#### Conclusion:

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject EMERGE™ Anterior Cervical Plate System has been shown to be substantially equivalent to legally marketed predicate devices.