The ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

Device Description

The ARTFX CORPECTOMY CAGE includes product range for cervical and lomber applications.

ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE-ANGLED
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE-ANGLED is used in lumber spine (T1-L5)

ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE is used , in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

ARTFX CORPECTOMY CAGE consisting of two parts, can easily be placed between the vertebra are the features to be distraction. Product is available in the cervical and lumbar spine, the upper and lower vertebrae, providing one to one contact with the angled surface. With gear structure with full contact surfaces of vertebrae forming the product surface, providing a tighter grip, eliminating the risk of slipping. Distraction prior to graft area at that provide a locking device which has a single-stage system after distraction.

The ARTFX CORPECTOMY CAGE, vertebral structure is used in cases where a portion or all of the damage. This damages the vertebral structure, tumors, fractures, and infections may occur due to.

The ARTFX CORPECTOMY CAGE is supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ISO 5832-2 and ASTM F136 .Various sizes of these components are available.

AI/ML Overview

The provided document is a 510(k) summary for the ArtFx Corpectomy Cages, a medical device. This document does not describe a study involving AI or software performance. Instead, it focuses on the substantial equivalence of the ArtFx Corpectomy Cages to a predicate device based on non-clinical mechanical testing.

Therefore, many of the requested categories related to AI performance, such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information, are not applicable to the content of this document.

However, I can provide information about the acceptance criteria and the study that proves the device meets those criteria based on the non-clinical testing described.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms within this 510(k) summary (e.g., "The device must withstand X N of compression"). However, the summary indicates that non-clinical testing was performed "according to the Guidance for Industry and FDA Staff Spinal System 510(k)s." This implies that the acceptance criteria are adherence to the performance requirements outlined in the specified ASTM standards and FDA guidance for spinal systems.

The reported device performance is that these tests were "performed" and presumably met the requirements of these standards to demonstrate substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Adherence to ASTM F2077 for dynamic & static compression, shear, and torsion tests	Tests performed according to ASTM F2077.
Adherence to ASTM F2267 for subsidence testing	Subsidence test performed according to ASTM F2267.
Successful expulsion testing	Expulsion test performed.
Overall mechanical performance substantially equivalent to predicate device	Concluded as substantially equivalent to predicate device K192117 based on testing.

2. Sample Size Used for the Test Set and Data Provenance

The document only mentions "Non-clinical testing including below tests are performed". For mechanical testing of medical devices, the "sample size" typically refers to the number of devices or representative constructs tested for each specific test. This specific number is not explicitly stated in the provided 510(k) summary.

Data Provenance: Not applicable as this is non-clinical mechanical testing, not human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth establishment with experts is relevant for clinical studies or AI/diagnostic device performance evaluation, not for mechanical device testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for clinical studies or AI/diagnostic device performance evaluation, not for mechanical device testing.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC study involves human readers interpreting cases, often with and without AI assistance. This document describes non-clinical mechanical testing of a physical medical device (corpectomy cages) and does not involve AI, human readers, or cases in this context.

6. Standalone Performance Study

Yes, in a sense, the non-clinical tests described (Dynamic Compression, Static Compression, Subsidence, Expulsion tests) represent a "standalone" evaluation of the device's mechanical performance without human interaction during the test itself. The performance is assessed against established engineering standards rather than against human performance.

7. Type of Ground Truth Used

The "ground truth" for this type of testing is established through industry standards and regulatory guidance. The device's performance is compared against the requirements and specifications outlined in the ASTM standards (F2077, F2267) and FDA guidance for spinal systems, which define acceptable mechanical properties and behaviors for such devices.

8. Sample Size for the Training Set

Not applicable. There is no AI or machine learning component mentioned that would require a training set. This is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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October 6, 2022

ARFTX Medical LLC Ozgen Ozfidan CEO 50 Laura Street #2524 Jacksonville, Florida 32202

Re: K211892

Trade/Device Name: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP, PLR Dated: September 6, 2022 Received: September 7, 2022

Dear Ozgen Ozfidan:

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 Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211892

Device Name ArtFx Corpectomy Cages (ESPINAX and DISTRACTANIA CORPECTOMY CAGES)

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 801 Subpart C)
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510(K) SUMMARY

Contact

Person/Applicant:

NAME: OZGEN OZFIDAN

COMPANY NAME: ARTFX MEDICAL LLC

ADDRESS: 50 LAURA ST N 25™ FLOOR, JAKCSONVILLE, FL, 32202 USA

PHONE: +1 917 445 2085

FAX: -

EMAIL: ozgen@ARTFXmed.com

ESTABLISHMENT REGISTRATION: 3017435639

DEVICE IDENTIFICATION:

TRADE NAME: ARTFX CORPECTOMY CAGES (ESPINAX and DISTRACTANIA CORPECTOMY

CAGES)

CLASSIFICATION NAME: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

REGULATION NUMBER:

888.3060 REVIEW PANEL:

ORTHOPEDIC PRODUCT CODE:

MQP,PLR

REASON FOR SUBMISSION: NEW DEVICE

FDA GUIDANCE DOCUMENTS: Guidance for Industry and FDA Staff Spinal System

510(k)s

INDICATIONS FOR USE:

The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage

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tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The ESPINAX and DISTRACTANIA CORPECTOMY CAGES is are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.

DEVICE DESCRIPTION:

The ARTFX CORPECTOMY CAGE includes product range for cervical and lomber applications.

ESPINAX SPINAL CERVICAL CORPECTOMY CAGE	used in cervical spine (C2- T1)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE-ANGLED
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE-ANGLED	used in lumber spine (T1-L5)

The ARTFX CORPECTOMY CAGE, vertebral structure is used in cases where a portion or all of the damage. This damages the vertebral structure, tumors, fractures, and infections may occur due to.

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NON-CLINICAL TESTING:

Non-clinical testing including below tests are performed according to the Guidance for Industry and FDA Staff Spinal System 510(k)s.

A Dynamic Compression Test (ASTM F2077)
A Dynamic Compression Shear Test (ASTM F2077)
A Dynamic Compression Torsion Test(ASTM F2077)
A Static Compression Test (ASTM F2077)
A Static Compression Shear Test (ASTM F2077)
A Static Compression Torsion Test (ASTM F2077)
A Subsidence Test Report(ASTM F2267)
A Expulsion test

PREDICATE DEVICE:

TRADE/ DEVICE NAME: SMALL VBR

REGULATION NUMBER: 21 CFR 888.3060

REGULATION NAME: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

REGULATORY CLASS: Class II

PRODUCT CODE: MQP, PLR

510(K) NUMBER: K192117

CONCLUSION:

The ARTFX CORPECTOMY CAGE has the same intended use and technological characteristics as the predicate device. Therefore, the ARTFX CORPECTOMY CAGE is substantially equivalent for its intended use.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.