RIGEL 3DR Anterior Cervical Interbody Fusion System

K200685 · MiRus, LLC · ODP · Jun 11, 2020 · Orthopedic

Device Facts

• Record ID: K200685
• Device Name: RIGEL 3DR Anterior Cervical Interbody Fusion System
• Applicant: MiRus, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jun 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

Device Story

RIGEL™ 3DR is an anterior cervical interbody fusion system; 3D-printed titanium lattice implant; used to facilitate spinal fusion in patients with degenerative disc disease. Implanted via anterior cervical surgical approach; requires supplemental fixation and bone graft (autogenous/allogenic). Device provides structural support to disc space; restores disc height/lordosis. Used by surgeons in clinical/OR settings. Benefits include stabilization of spinal segment; reduction of radicular symptoms.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical performance assessed via static and fatigue construct testing per ASTM F2077-18 (compression, compression-shear, torsion), ASTM F2267-04 (subsidence), and expulsion testing.

Technological Characteristics

Implants manufactured from Titanium 6AL-4V ELI (ASTM F3001-14); instrumentation from stainless steel (ASTM F899). 3D-printed randomized-lattice structure. Various footprints, heights, and lordotic angles. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and radicular symptoms at one or two contiguous levels (C2-T1). Requires six weeks of failed non-operative treatment. Contraindicated in patients without skeletal maturity.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• RIGEL™ PEEK Anterior Cervical Interbody Fusion System (K190618)
• EIT Cellular Titanium® Cervical Cage (K170503)

Submission Summary (Full Text)

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June 11, 2020

MiRus, LLC Mr. Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta, Georgia 30062

Re: K200685

Trade/Device Name: RIGEL™ 3DR Anterior Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 13, 2020 Received: March 16, 2020

Dear Mr. Bauman:

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.

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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 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.

Brent Showalter, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known) Not Known K200685

Device Name

#### RIGEL™ 3DR Anterior Cervical Interbody Fusion System

Indications for Use (Describe)

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

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

� Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K200685 - 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

| I. SUBMITTER | MiRus™, LLC<br>1755 West Oak Parkway<br>Suite 100<br>Marietta, Georgia 30062<br>Tel: [phone]<br>Fax: [phone] |
|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL<br>CORRESPONDENT | Jordan Bauman<br>VP of Regulatory Affairs<br>MiRus™, LLC<br>1755 West Oak Parkway<br>Suite 100<br>Marietta, Georgia 30062<br>Tel: [phone]<br>Fax: [phone] |
| III. DATE PREPARED | March 13, 2020 |
| IV. DEVICE<br>Name of Device<br>Common Name<br>Classification Name<br>Regulatory Class<br>Product Codes<br>Submission Type | RIGEL™ 3DR Anterior Cervical Interbody Fusion<br>System<br>Intervertebral body fusion device<br>21 CFR 888.3080<br>Class II<br>ODP<br>Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate<br>RIGEL™ PEEK Anterior Cervical Interbody Fusion System<br>(K190618)<br>Additional Predicate<br>EIT Cellular Titanium® Cervical Cage (K170503) |

#### VI. DEVICE DESCRIPTION

The RIGEL™ 3DR (3D-printed Randomized-lattice) Anterior Cervical Interbody Fusion System consist of implants manufactured from Titanium 6AL-4V ELI per ASTM F3001-14 and instrumentation manufactured from stainless steel per ASTM F899. The Interbody Fusion Device is offered in various footprints, heights, and lordosis to accommodate different patient anatomy and the Anterior Cervical Surgical Approach. The implants will be provided sterile and are intended for single use only.

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#### VII. INDICATIONS FOR USE

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation.

## VIII. PREDICATE DEVICE COMPARISON

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, sizes, and materials.

## IX. PERFORMANCE DATA

The mechanical performance profile of the RIGEL™ 3DR Anterior Cervical Interbody Fusion System was assessed through static and fatigue construct testing in accordance with the following test methods:

- Static and dynamic compression testing (ASTM F2077-18) ●
- Static and dynamic compression shear testing (ASTM F2077-18) ●
- Static and dynamic torsion testing (ASTM F2077-18) .
- . Subsidence testing (ASTM F2267-04)
- . Expulsion testing

## X. CONCLUSONS

The RIGEL™ 3DR Anterior Cervical Interbody Fusion System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, sizes, and materials. Performance data demonstrate that the RIGEL™ 3DR Anterior Cervical Interbody Fusion System is substantially equivalent to legally marketed predicate systems.