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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Eminent Spine 3D Cervical Interbody Fusion System. It aims to prove the substantial equivalence of the new device to existing predicate devices.

Here's the breakdown of the acceptance criteria and the study information as requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Static and Dynamic Compression Bending (per ASTM F2077)	Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document)	"Results support that the subject device performs as well as or better than the chosen acceptance criteria."
Static and Dynamic Torsion (per ASTM F2077)	Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document)	"Results support that the subject device performs as well as or better than the chosen acceptance criteria."
Expulsion	Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document)	"Results support that the subject device performs as well as or better than the chosen acceptance criteria."
Subsidence (per ASTM F2267)	Performance meets or exceeds established benchmarks for intervertebral body fusion devices, demonstrated by comparison to predicate devices. (Exact numerical criteria not specified in the document)	"Results support that the subject device performs as well as or better than the chosen acceptance criteria."

2. Sample size used for the test set and the data provenance

The document refers to "mechanical testing" and "results," but does not specify the sample size for the test set used in the mechanical tests.
The data provenance is from mechanical testing of the device, likely conducted in a laboratory setting. The country of origin and whether it was retrospective or prospective is not mentioned for the mechanical testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the study presented is a mechanical performance study, not a clinical study involving expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable for a mechanical testing study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on the mechanical substantial equivalence of a medical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" is established by the specified ASTM standards (F2077 and F2267) and potentially by comparing the performance to the predicate devices. These standards define the acceptable mechanical properties for such devices.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" for AI or other data-driven modeling in this device submission. The device is a physical implant, and the testing described is mechanical.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set mentioned or implied in the provided document.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

☑ 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)

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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 Spine2004 Ventura Dr. Suite #100Plano, TX 75093
Date:	01/25/2023
Contact Person:	Jennifer Palinchik, President
Contact Telephone:	(440) 935-3282
Contact Fax:	(440) 933-7839
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)The primary predicate device has never been subject to a recall.
Reference Predicate Device:	Tailored-C Cervical Interbody Fusion System (200458)The reference predicate devices have never been subject to a recall.

Device Description:

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 3DCervical InterbodyFusion System(Subject Device)	Eminent SpineInterbody FusionSystem (K090064)	Tailored-C CervicalInterbody Fusion System(200458)	Comparison
Classification Name	Intervertebral BodyFusion Device	Intervertebral BodyFusion Device	Intervertebral Body FusionDevice	Equivalent
Regulation	888.3080	888.3080	888.3080	Equivalent
Product Code	ODP	ODP	ODP	Equivalent
Indications for Use	The Eminent Spine3D CervicalInterbody FusionSystem is indicatedfor intervertebralbody fusion inskeletally maturepatients withdegenerative discdisease (DDD) ofthe cervical spine atone disc level fromthe C2-C3 disc tothe C7-T1 disc.DDD is defined asdiscogenic pain withdegeneration of thedisc confirmed byhistory andradiographicstudies. The devicesystem is designedfor use withsupplementalfixation andautograft tofacilitate fusion.Patients should haveat least six (6)weeks of non-operative treatmentprior to treatment	The Eminent SpineInterbody Fusion System(Copperhead) is indicatedfor intervertebral bodyfusion in skeletallymature patients withdegenerative disc disease(DDD) of the cervicalspine at one disc levelfrom the C2-C3 disc tothe C7-T1 disc. DDD isdefined as discogenicpain with degeneration ofthe disc confirmed byhistory and radiographicstudies. The devicesystem is designed foruse with supplementalfixation and autograft tofacilitate fusion. Patientsshould have at least six(6) weeks of non-operative treatment priorto treatment with anintervertebral cage.	The Tailored-C CervicalInterbody Fusion Devices areindicated for use in skeletallymaturepatients with degenerativedisc disease (DDD) of thecervical spine withaccompanying radicularsymptoms at one disc level.DDD is defined asdiscogenic pain withdegeneration of the discconfirmed by patient historyand radiographic studies.Tailored-C Cervical implantsare used tofacilitate intervertebral bodyfusion in the cervical spineand are placed via an anteriorapproachat one disc level (C2-T1)using autograft bone.Tailored-C Cervical implantsare to be used withsupplemental fixation.Patients should have at leastsix (6) weeks of non-operative treatmentprior to treatment with anintervertebral cage.	Equivalent
Item	Eminent Spine 3DCervical InterbodyFusion System(Subject Device)	Eminent SpineInterbody FusionSystem (K090064)	Tailored-C CervicalInterbody Fusion System(200458)	Comparison
	with anintervertebral cage.
Description	The Eminent Spine3D CervicalInterbody FusionSystem is comprisedof various sizes andconfiguration toaccommodateindividual patientanatomy. Thedevice is a hollowrectangular shapedblock, which isavailable in aparallel or lordoticconfigurations.Copperhead ishollow to allow forplacement of bonegraft. There areteeth on the superiorand inferior surfacesof the device toinhibit movement ofthe device.	The Eminent SpineInterbody Fusion Systemis comprised of varioussizes and configuration toaccommodate individualpatient anatomy. Theconfigurations aredesigned to provide thesurgeon with differentsurgical approachoptions.	The Tailored-C CervicalInterbody Fusion System isan intervertebral spinalfixation systemcomprised of additivelymanufactured cervicalinterbody spacers. They aredesigned to providemechanical support to thecervical spine whilearthrodesis occurs. Theimplant has a partiallyporous construction and anopen architecture with a largevariety of footprints andlordosisangles to optimize patient fit.The footprints are offered at11x13mm, 12x14mm,14x16mm,16x18mm, and 17x19mm.The lordosis is offered at 0°,4°, and 7°. The height rangesfrom 5mmto 12mm in 1mm increments.	Equivalent
Footprints	14x12 mm, 15x13mm,17x12 mm,17x14 mm, 19x16mm	14x12 mm, 15x13 mm,17x12 mm,17x14 mm, 19x16 mm	11x13mm,12x14mm,14x16mm,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 perASTM 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.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.