Boomerang™ Anterior Cervical Plate System

K190227 · Choicespine, LP · KWQ · May 1, 2019 · Orthopedic

Device Facts

• Record ID: K190227
• Device Name: Boomerang™ Anterior Cervical Plate System
• Applicant: Choicespine, LP
• Product Code: KWQ · Orthopedic
• Decision Date: May 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion. WARNING. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

Boomerang™ Anterior Cervical Plate System provides anterior cervical fixation (C2-T1). System comprises titanium alloy bone plates and screws; used with stainless steel instruments. Surgeon implants device during spinal surgery to stabilize vertebral bodies. Unique design requires only one screw per adjacent vertebral body, differing from traditional two-screw predicates. Mechanical stability achieved via plate-screw construct. Benefits include spinal stabilization for conditions like DDD, trauma, and deformity. Device provided non-sterile; requires user steam sterilization.

Clinical Evidence

Bench testing only. Mechanical testing including static and dynamic compression bending and static torsion performed per ASTM F1717-18. Results demonstrated that the device met pre-defined acceptance criteria and is substantially equivalent to predicate devices.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 for plates/screws; stainless steels (455, 465, 17-4) per ASTM A564 and ASTM F899 for instruments. Fixation: Anterior cervical plate system. Configuration: Single screw per adjacent vertebral body. Sterilization: User-performed steam sterilization. Non-sterile delivery.

Indications for Use

Indicated for anterior cervical fixation (C2-T1) in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion. Contraindicated for posterior element (pedicle) 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

• DePuy Synthes Anterior CSLP System (K030866)
• ChoiceSpine Ambassador™ (K143576)
• Eurosurgical, SA ORIA Zenith (K030500)
• DePuy Motech AcroMed – DOC™ Ventral Cervical Stablization System (K982443)
• Stryker Spine – Aviator Plate (K083562)

Submission Summary (Full Text)

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May 1, 2019

ChoiceSpine, LP Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919

Re: K190227

Trade/Device Name: Boomerang™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: February 1, 2019 Received: February 5, 2019

Dear Ms. Finch:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

### K190227

Device Name

Boomerang™Anterior Cervical Plate System

Indications for Use (Describe)

The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.

WARNING. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 7. 510(k) Summary

| Date: | February 4, 2019 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ChoiceSpine, LP<br>400 Erin Drive<br>Knoxville, TN 37919 |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed Proprietary<br>Trade Name: | Boomerang™ Anterior Cervical Plate System |
| Product Class: | Class II |
| Classification Name:<br>Device Product Code: | 888.3060 - Spinal Intervertebral Body Fixation Orthosis<br>KWQ |
| Purpose of<br>Submission: | The purpose of this submission is to gain clearance for a new anterior cervical plate<br>and screw system. |
| Device Description: | The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anterior<br>screw fixation to the cervical spine. The system consists of a variety of bone plates<br>and screws made from titanium alloy (T-6Al-4V ELI) per ASTM F136 and a set of<br>instruments made from stainless steels (455, 465 and 17-4) per ASTM A564 and ASTM<br>F899. The system components are provided non-sterile and must be steam sterilized<br>by the user prior to use. |
| Indications for Use: | The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anterior<br>cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD)<br>(defined as neck pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or<br>dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or<br>lordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| | WARNING: This device is not intended for screw attachment or fixation to the<br>posterior elements (pedicles) of the cervical, thoracic or lumbar spine. |
| Summary of the<br>Technological<br>Characteristics | As established in this submission, equivalency of the ChoiceSpine Boomerang™<br>Anterior Cervical Plate system to its predicate devices is based on similarities in the<br>indications for/intended use, design, product offering, materials used and levels of<br>attachment. |
| Summary of the<br>Performance Data: | Mechanical testing (static and dynamic compression bending and static torsion) per<br>ASTM F1717-18 was performed to demonstrate that the ChoiceSpine<br>Boomerang™ Anterior Cervical Plate system is substantially equivalent to its<br>predicate devices. The test results indicate that the pre-defined acceptance<br>criteria were met. |

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The ChoiceSpine Boomerang™ Anterior Cervical Plate system has the same Conclusion: indications, technological characteristics, and principles of operation as its predicates of traditional design. The proposed design differs from its predicates in that only one screw is required to be placed in each adjacent vertebral body as opposed to two. Despite this difference, the mechanical testing results and predicate data provided in Attachment 4 further demonstrate substantial equivalence to the predicate devices.

| Predicate Devices: | Primary predicate: | DePuy Synthes Anterior CSLP System (K030866) |
|--------------------|------------------------|-------------------------------------------------------------------------------|
| | Additional Predicates: | ChoiceSpine Ambassador™ (K143576) |
| | | Eurosurgical, SA ORIA Zenith (K030500) |
| | | DePuy Motech AcroMed – DOC™ Ventral Cervical<br>Stablization System (K982443) |
| | | Stryker Spine – Aviator Plate (K083562) |