Eminent Spine 3D Cervical Interbody Fusion System

K212701 · Eminent Spine · ODP · Feb 6, 2023 · Orthopedic

Device Facts

• Record ID: K212701
• Device Name: Eminent Spine 3D Cervical Interbody Fusion System
• Applicant: Eminent Spine
• Product Code: ODP · Orthopedic
• Decision Date: Feb 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eminent Spine 3D Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Eminent Spine 3D Cervical Interbody Fusion System is an additively manufactured intervertebral body fusion device; hollow rectangular block design; available in parallel or lordotic configurations; features surface teeth to inhibit movement; intended for placement of bone graft to facilitate fusion. Used in cervical spine surgery; implanted by surgeons; provides mechanical support to the cervical spine while arthrodesis occurs. Device is used with supplemental fixation. Benefits include stabilization of the spinal segment in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. Mechanical testing included static and dynamic compression bending (ASTM F2077), static and dynamic torsion (ASTM F2077), expulsion, and subsidence (ASTM F2267). Results demonstrate performance equivalent to or better than predicate devices.

Technological Characteristics

Material: Ti-6Al-4V ELI per ASTM F3001. Design: Hollow rectangular block, parallel or lordotic configurations, surface teeth. Dimensions: Footprints 14x12mm to 19x16mm, heights 5-12mm, lordotic angles 0° and 6°. Manufacturing: Additive manufacturing. Sterilization: Not specified.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one level (C2-C3 to C7-T1). Requires supplemental fixation and autograft. Patients must have failed at least 6 weeks of non-operative treatment.

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

• Eminent Spine Copperhead Interbody Fusion System (K090064)

Reference Devices

• Tailored-C Cervical Interbody Fusion System (200458)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 6, 2023

Eminent Spine % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K212701

Trade/Device Name: Eminent Spine 3D Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 25, 2023 Received: January 25, 2023

Dear Jennifer Palinchik:

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.

# Katherine D. Kavlock -S

for

Brent Showalter, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K212701 Page 1 of 1

Device Name

Eminent Spine 3D Cervical Interbody Fusion System

#### Indications for Use (Describe)

The Eminent Spine 3D Cervical Interbody Fusion is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

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

| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 3 |
|-----------------------------------------------------------------------------------------|----------------------------------|
|-----------------------------------------------------------------------------------------|----------------------------------|

|| | Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a caduceus wrapped around it, set against a golden oval. The word "EMINENT" is written in a dark green font above the word "SPINE", which is in a lighter color.

# 510(k) Summary

| Submitted By: | Eminent Spine<br>2004 Ventura Dr. Suite #100<br>Plano, TX 75093 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date: | 01/25/2023 |
| Contact Person: | Jennifer Palinchik, President |
| Contact Telephone: | [phone] |
| Contact Fax: | [phone] |
| Device Trade Name: | Eminent Spine 3D Cervical Interbody Fusion System |
| Common Name: | Intervertebral Body Fusion Device |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Cervical |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | ODP |
| Primary Predicate Device: | Eminent Spine Copperhead Interbody Fusion System (K090064)<br>The primary predicate device has never been subject to a recall. |
| Reference Predicate Device: | Tailored-C Cervical Interbody Fusion System (200458)<br>The reference predicate devices have never been subject to a recall. |

#### Device Description:

The Eminent Spine 3D Cervical Interbody Fusion System is comprised of various sizes and configuration to accommodate individual patient anatomy. The device is a hollow rectangular shaped block, which is available in a parallel or lordotic configurations. The device is hollow to allow for placement of bone graft. There are teeth on the superior and inferior surfaces of the device to inhibit movement of the device.

This submission is to introduce additively manufactured versions of the implants to the existing Eminent Spine Copperhead Interbody Fusion System.

#### Indications for Use:

The Eminent Spine 3D Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

#### Summary of Technological Characteristics:

The Eminent Spine 3D Cervical Interbody Fusion System and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:

- Design features

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Image /page/4/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a snake wrapped around it, set against a circular backdrop with green accents. The word "EMINENT" is prominently displayed above the word "SPINE" in a smaller font size.

- Intended use .
- Materials
- Dimensions
- . Function

| Table 1: Dimensions and Technological Characteristics Comparison | |
|------------------------------------------------------------------|--|
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| Item | Eminent Spine 3D<br>Cervical Interbody<br>Fusion System<br>(Subject Device) | Eminent Spine<br>Interbody Fusion<br>System (K090064) | Tailored-C Cervical<br>Interbody Fusion System<br>(200458) | Comparison |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification Name | Intervertebral Body<br>Fusion Device | Intervertebral Body<br>Fusion Device | Intervertebral Body Fusion<br>Device | Equivalent |
| Regulation | 888.3080 | 888.3080 | 888.3080 | Equivalent |
| Product Code | ODP | ODP | ODP | Equivalent |
| Indications for Use | The Eminent Spine<br>3D Cervical<br>Interbody Fusion<br>System is indicated<br>for intervertebral<br>body fusion in<br>skeletally mature<br>patients with<br>degenerative disc<br>disease (DDD) of<br>the cervical spine at<br>one disc level from<br>the C2-C3 disc to<br>the C7-T1 disc.<br>DDD is defined as<br>discogenic pain with<br>degeneration of the<br>disc confirmed by<br>history and<br>radiographic<br>studies. The device<br>system is designed<br>for use with<br>supplemental<br>fixation and<br>autograft to<br>facilitate fusion.<br>Patients should have<br>at least six (6)<br>weeks of non-<br>operative treatment<br>prior to treatment | The Eminent Spine<br>Interbody Fusion System<br>(Copperhead) is indicated<br>for intervertebral body<br>fusion in skeletally<br>mature patients with<br>degenerative disc disease<br>(DDD) of the cervical<br>spine at one disc level<br>from the C2-C3 disc to<br>the C7-T1 disc. DDD is<br>defined as discogenic<br>pain with degeneration of<br>the disc confirmed by<br>history and radiographic<br>studies. The device<br>system is designed for<br>use with supplemental<br>fixation and autograft to<br>facilitate fusion. Patients<br>should have at least six<br>(6) weeks of non-<br>operative treatment prior<br>to treatment with an<br>intervertebral cage. | The Tailored-C Cervical<br>Interbody Fusion Devices are<br>indicated for use in skeletally<br>mature<br>patients with degenerative<br>disc disease (DDD) of the<br>cervical spine with<br>accompanying radicular<br>symptoms at one disc level.<br>DDD is defined as<br>discogenic pain with<br>degeneration of the disc<br>confirmed by patient history<br>and radiographic studies.<br>Tailored-C Cervical implants<br>are used to<br>facilitate intervertebral body<br>fusion in the cervical spine<br>and are placed via an anterior<br>approach<br>at one disc level (C2-T1)<br>using autograft bone.<br>Tailored-C Cervical implants<br>are to be used with<br>supplemental fixation.<br>Patients should have at least<br>six (6) weeks of non-<br>operative treatment<br>prior to treatment with an<br>intervertebral cage. | Equivalent |
| Item | Eminent Spine 3D<br>Cervical Interbody<br>Fusion System<br>(Subject Device) | Eminent Spine<br>Interbody Fusion<br>System (K090064) | Tailored-C Cervical<br>Interbody Fusion System<br>(200458) | Comparison |
| | with an<br>intervertebral cage. | | | |
| Description | The Eminent Spine<br>3D Cervical<br>Interbody Fusion<br>System is comprised<br>of various sizes and<br>configuration to<br>accommodate<br>individual patient<br>anatomy. The<br>device is a hollow<br>rectangular shaped<br>block, which is<br>available in a<br>parallel or lordotic<br>configurations.<br>Copperhead is<br>hollow to allow for<br>placement of bone<br>graft. There are<br>teeth on the superior<br>and inferior surfaces<br>of the device to<br>inhibit movement of<br>the device. | The Eminent Spine<br>Interbody Fusion System<br>is comprised of various<br>sizes and configuration to<br>accommodate individual<br>patient anatomy. The<br>configurations are<br>designed to provide the<br>surgeon with different<br>surgical approach<br>options. | The Tailored-C Cervical<br>Interbody Fusion System is<br>an intervertebral spinal<br>fixation system<br>comprised of additively<br>manufactured cervical<br>interbody spacers. They are<br>designed to provide<br>mechanical support to the<br>cervical spine while<br>arthrodesis occurs. The<br>implant has a partially<br>porous construction and an<br>open architecture with a large<br>variety of footprints and<br>lordosis<br>angles to optimize patient fit.<br>The footprints are offered at<br>11x13mm, 12x14mm,<br>14x16mm,<br>16x18mm, and 17x19mm.<br>The lordosis is offered at 0°,<br>4°, and 7°. The height ranges<br>from 5mm<br>to 12mm in 1mm increments. | Equivalent |
| Footprints | 14x12 mm, 15x13<br>mm,<br>17x12 mm,<br>17x14 mm, 19x16<br>mm | 14x12 mm, 15x13 mm,<br>17x12 mm,<br>17x14 mm, 19x16 mm | 11x13mm,12x14mm,<br>14x16mm,<br>16x18mm, 17x19mm | Equivalent |
| Heights | 5-12 mm | 5-12 mm | 5-12 mm | Equivalent |
| Lordotic angle | 0°, 6° | 0°, 6° | 0°, 4°, 7° | Equivalent |
| Material | Ti-6Al-4V ELI per<br>ASTM F3001 | PEEK Optima LT1 | Ti-6Al-4V per ASTM F3001 | Equivalent |

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Image /page/5/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a snake wrapped around it, set against a golden circle. The text "EMINENT" is in a larger, bold, green font, while "SPINE" is in a smaller, lighter green font below it.

### Mechanical Testing:

Substantial equivalence is supported by the results of mechanical testing, including:

- Static and dynamic compression bending per ASTM 2077 ●
- Static and dynamic torsion per ASTM 2077 ●
- . Expulsion

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Image /page/6/Picture/0 description: The image is a logo for Eminent Spine. The logo features a golden sword with a caduceus wrapped around it, set against a golden circle with green accents. Below the emblem, the word "EMINENT" is written in a bold, teal font, with the word "SPINE" in a smaller font underneath.

- Subsidence per ASTM F2267
Results support that the subject device performs as well as or better than the chosen acceptance criteria.

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.