The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

The MONDRIAN ALIF Cage with Supplementary Fixation Plate System is intended for use with either two or four titanium alloy screws which are provided with the system. When used with screws and implants with lordotic angles ≤20°, the MONDRIAN ALIF Cage with Supplementary Fixation Plate System is a stand-alone interbody fusion device. If the physician chooses to use fewer than the number of screws compatible with the plate, then a supplemental spinal fixation system that is cleared for use in the lumbosacral spine must be used. Hyperlordotic cage offerings (>20°) require the use of a supplemental fixation system (e.g. facet screws or posterior fixation).

Device Description

The MONDRIAN ALIF Cage with Supplemental Fixation Plate System are anterior lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals. The system is comprised of spacers, plates, screws and instruments to facilitate the installation of the implants. The spacers are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136, plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

AI/ML Overview

The document describes the MONDRIAN ALIF Cage with Supplementary Fixation Plate System, an intervertebral body fusion device.

Acceptance Criteria and Reported Device Performance:

The document states that the rationale for substantial equivalence is based on the following general characteristics being similar to predicate devices:

Acceptance Criteria (based on similar characteristics to predicate devices K160597 and K192863)	Reported Device Performance (Summary)
Intended Use	Similar to K160597 and K192863.
Indications for Use	Similar to K160597 and K192863.
Materials	MONDRIAN ALIF Cage with Supplemental Fixation Plate implants manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136. Instruments manufactured from Stainless Steel per ASTM F899. These are commonly used materials in orthopedic implants and instruments and similar to materials used in K160597 and K192863.
Design Features	Similar to those in currently marketed devices cleared in K160597 and K192863. Design differences have not identified any issues that would impact the safety and effectiveness of the device.
Sterilization	Device offered in non-sterile configuration, requiring steam sterilization by the user prior to use, which is similar to the devices cleared in K160597 and K192863.
Non-Clinical Tests	The device underwent: - Axial Dynamic Compression (per ASTM F2077) - Screw Push-Out Testing - Plate-Cage Disassembly Testing Results indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.
Clinical Tests	No specific clinical tests are mentioned as being performed for this submission ("o" is listed under clinical tests with no further details). The document relies on substantial equivalence to predicate devices, implying that clinical performance is considered similar based on the similarities in the device's characteristics and the non-clinical test results.

Study to Prove Device Meets Acceptance Criteria:

The document describes a non-clinical study to demonstrate substantial equivalence to previously cleared predicate devices (K192863 and K160597).

A table of acceptance criteria and the reported device performance: This is provided above.
Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for the non-clinical tests (Axial Dynamic Compression, Screw Push-Out, Plate-Cage Disassembly Testing). It also does not mention data provenance as these are laboratory/bench tests, not patient data studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These were non-clinical, mechanical tests performed according to ASTM standards. Expert consensus would not be used to establish "ground truth" for these types of tests; rather, the results would be compared against predefined criteria from the standard or predicate device performance.
Adjudication method for the test set: Not applicable. This was a non-clinical, mechanical testing study, not a study requiring adjudication of expert interpretations.
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: Not applicable. This device is an implantable medical device (ALIF cage), not an AI-assisted diagnostic or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device. The non-clinical tests assess the mechanical performance of the physical device.
The type of ground truth used: For the non-clinical tests, the "ground truth" or reference for acceptance would be the performance criteria (e.g., strength, durability) specified by relevant ASTM standards (e.g., ASTM F2077) and/or comparison to the mechanical performance of the predicate device(s).
The sample size for the training set: Not applicable. This is a non-clinical performance study of a physical medical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device submission.

Summary

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September 15, 2022

CTL Medical Corporation % Dhaval Saraiya Regulatory/Quality Consultant Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, District of Columbia 20003

Re: K213641

Trade/Device Name: MONDRIAN ALIF Cage with Supplementary Fixation Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: September 6, 2022 Received: September 6, 2022

Dear Dhaval Saraiya:

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 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 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: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213641

Device Name

MONDRIAN ALIF Cage with Supplemental Fixation Plate 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 801 Subpart C)
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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the MONDRIAN ALIF Cage with Supplemental Fixation Plate System 510(k) premarket notification.

Sponsor:	CTL Medical CorporationSean Suh4550 Excel PkwySte 300Addison, TX 75001
Contact Person:	Dhaval SaraiyaOmni Strategic Solutions, LLC.Regulatory/Quality ConsultantEmail: omniregsolutions@gmail.com
Date:	November 15, 2021
Subject Device:	Trade Name: MONDRIAN ALIF Cage with Supplemental Fixation PlateSystem
	Common Name: Lumbar Intervertebral Fusion DeviceClassification Name:MAX - Intervertebral Fusion Device with Bone Graft, Lumbar(21 CFR 888.3080)OVD - Intervertebral Fusion Device with Integrated Fixation, Lumbar(21 CFR 888.3080)
Predicate Device(s):
	Primary Predicate: K192863 MONDRIAN™ Lumbar Interbody Fusion Cage System CTL Medical Corporation
	Reference Device: K160597 INDEPENDENCE® Spacers Globus Medical Inc.
Purpose andDevice Description:	The purpose of this submission is to request clearance for the newMONDRIAN ALIF Cage with Supplemental Fixation Plate System.The MONDRIAN ALIF Cage with Supplemental Fixation Plate Systemare anterior lumbar interbody fusion devices used to provide structuralstability in skeletally mature individuals. The system is comprised ofspacers, plates, screws and instruments to facilitate the installation ofthe implants. The spacers are manufactured from PEEK per ASTMF2026 and/or Titanium Alloy per ASTM F136, plates and screws aremanufactured from Titanium Alloy per ASTM F136. The instrumentsare manufactured from Stainless Steel per ASTM F899. Implants andinstruments will be provided in non-sterile configuration and will requiresteam sterilization prior to use.

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Intended Use and Indications for Use:

The MONDRIAN ALIF Cage with Supplementary Fixation Plate System (MONDRIAN ALIF Cage) is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of . the following characteristics:
.
. Intended Use: The intended use is similar to the intended use cleared in K160597 and K192863.
Indications for Use: The indications for use are similar to the indications for use cleared in K160597 and K192863.
. Materials: The MONDRIAN ALIF Cage with Supplemental Fixation Plate implants are manufactured from PEEK per ASTM F2026 and/or Titanium Alloy per ASTM F136 and instruments are manufactured from Stainless Steel per ASTM F899 which are commonly used materials in orthopedic implants and instruments and similar to materials used in K160597 and K192863.
. Design Features: The design features for the MONDRIAN ALIF Cage with Supplemental Fixation Plate System implants and instruments are similar to those in currently marketed devices cleared in K160597 and K192863. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
Sterilization: The MONDRIAN ALIF Cage with Supplemental Fixation ● Plate implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use is similar to the devices cleared in K160597 and K192863.
Summary of Performance Data (Nonclinical and/or Clinical):

Substantial Equivalence Conclusion:

Non-Clinical Tests: .
- o Axial Dynamic Compression (per ASTM F2077)
- o Screw Push-Out Testing
- o Plate-Cage Disassembly Testing
Clinical Tests: ●
- o

The MONDRIAN ALIF Cage with Supplemental Fixation Plate System has shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that the device will perform within the intended uses and no new issues of safety and effectiveness have been raised.

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.