The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The Axis Spine Technologies ALIF is an interfixated interbody system consisting of a modular interbody spacer manufactured from Ti6Al4V. The system is designed to be assembled in vivo. The spacer comprises of two endplates and a central core. Each component is available in a variety of shapes and sizes to allow the assembled device to suit the individual pathology and anatomical conditions of the patient.

The Axis Spine Technologies ALIF System intervertebral fusion device is designed to address lumbar pathologies utilizing placement through an anterior approach. The device's hollow core or graft aperture allows for packing of autogenous and/or allogeneic bone graft to help promote a solid fusion. A rough surface on the device endplates serves to grip the adjacent vertebrae to resist migration and expulsion of the device, alternately models with protrusions on the device endplates grip the adjacent vertebrae to resist migration and aid in expulsion resistance. The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

The ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel deqenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.

The Axis Spine Technologies ALIF implant is composed of:

one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
one (1) cover plate manufactured from PEEK-Optima HA Enhanced.

AI/ML Overview

This FDA 510(k) summary provides information for a medical device called the "Axis Spine Technologies ALIF," an intervertebral body fusion device.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold format that would typically be found in a performance study for, for example, diagnostic accuracy. Instead, it states that non-clinical testing was performed to demonstrate substantial equivalence to predicate devices. The reported device performance is that it "meets or exceeds the performance of the predicate device and does not introduce any new risks."

Therefore, the "acceptance criteria" can be inferred as meeting the established standards for intervertebral body fusion devices, and the reported performance is that the device successfully met these standards.

Acceptance Criteria (Inferred from testing standards)	Reported Device Performance
Demonstrate performance per ASTM F2077 for static and dynamic compression.	Met or exceeded the performance of the predicate device.
Demonstrate performance per ASTM F2077 for static and dynamic compression shear.	Met or exceeded the performance of the predicate device.
Demonstrate performance per ASTM F2267 for subsidence.	Met or exceeded the performance of the predicate device.
Demonstrate performance for expulsion and axial pushout of retention device.	Met or exceeded the performance of the predicate device.
Not introduce any new risks compared to predicate devices.	Does not introduce any new risks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not provide specific sample sizes for the non-clinical tests. It refers to "nonclinical testing" without detailing the number of specimens tested for each type of evaluation (e.g., number of interbody spacers for compression testing).

The studies performed are non-clinical (mechanical/physical tests), not involving human or animal subjects, so terms like "country of origin of the data," "retrospective," or "prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. The studies conducted are non-clinical mechanical tests, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable, as the tests are non-clinical mechanical validations.

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:

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence." This device is a physical 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. This device is a physical implant, not an algorithm.

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

This information is not applicable. For non-clinical mechanical tests, "ground truth" would refer to the physical properties and performance metrics established by the ASTM standards, not clinical or pathological diagnoses. The "ground truth" for these tests are the specified parameters and methodologies defined by the ASTM standards (F2077, F2267).

8. The sample size for the training set:

This information is not applicable. There is no "training set" for physical device testing as there would be for an AI algorithm.

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

This information is not applicable, as there is no training set for this type of submission.

Summary

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September 29, 2021

Axis Spine Technologies Ltd Edwin Lindsay OA/RA Consultant Suite 204, 54-56 Victoria Street, St. Albans, AL1 3HZ United Kingdom

Re: K210590

Trade/Device Name: Axis Spine Technologies ALIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: August 20, 2021 Received: September 2, 2021

Dear Edwin Lindsay:

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

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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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent L. 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

510(k) Number (if known) K210590

Device Name Axis Spine Technologies ALIF

Indications for Use (Describe)

The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1.

For use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

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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510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

Axis Spine Technologies Ltd

Submitter's Address:

Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans, AL1 3HZ United Kingdom

Telephone: +44 (0) 330 123 0535

Establishment Registration Number:

3016668776

Contact Person:

Edwin Lindsay

Telephone +44 (0) 7917134922

Date Prepared:

19th February 2021

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Below summaries the Device Classification Information regarding the Axis Spine Technologies ALIF:

Primary Product Code:

RegulationNumber	Device	DeviceClass	ProductCode	ClassificationPanel
883.3080	Axis Spine ALIF	2	OVD	Orthopedic

Device Trade Name:

Axis Spine Technologies ALIF

Device Common Name:

Intervertebral Body Fusion Device

Intended/ Indications Use:

The ALIF System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to -S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s).

The ALIF System 10° - 20° lordotic cages may be used as a standalone system. The ALIF System 25° - 40° lordotic cages must be used with supplemental internal spinal fixation systems (i.e., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

Summary of Substantial Equivalence:

The following predicate devices have been chosen that the Axis Spine Technologies ALIF can claim equivalence with, and these are detailed below:

● Primary Predicate:

K160597 - Globus Medical Independence MIS

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Secondary Predicate: ●

K200352 - Axis Spine ALIF

K132596 - Custom Spine Optimus ALIF System

K170592 - NuVasive BASE Interfixed Titanium System

Any technical differences have been justified, both scientifically and using performance testing. These do not affect the safety or effectiveness of the proposed device.

Device Description:

The Axis Spine Technologies ALIF implant is composed of:

one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) ● conforming to ASTM F136 and ISO 5832-3.
. one (1) inferior endplate manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
. one (1) core manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
. three (3) bone screws manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 and ISO 5832-3.
. one (1) cover plate manufactured from PEEK-Optima HA Enhanced.

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Technological Characteristics:

As was established in this submission, the subject Axis Spine Technologies ALIF is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States.

The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function, and range of sizes.

Non-Clinical Tests (Performance/Physical Data):

Nonclinical testing was performed to demonstrate that the subject BASE Interfixated Titanium System is substantially equivalent to other predicate devices. The following testing was performed:

. Static and dynamic compression testing per ASTM F2077
Static and dynamic compression shear testing per ASTM F2077
Subsidence testing per ASTM F2267 ●
Expulsion and Axial Pushout of Retention Device testing .

The results of these studies show that the Axis Spine Technologies ALIF meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.

Animal Studies

No animal studies were conducted as part of submission to prove substantial equivalence.

Clinical Studies

No clinical studies were conducted as part of submission to prove substantial equivalence.

Safety and Effectiveness/Conclusion:

Based on the information presented in these 510(k) premarket notifications the Axis Spine Technologies ALIF is considered substantially equivalent. The Axis Spine Technologies ALIF is as safe and effective as the currently marketed predicate devices.

Based on testing and comparison with the predicate devices, the Axis Spine Technologies ALIF indicated no adverse indications or results. It is our determination that the Axis Spine Technologies ALIF is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.

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.