MONET™ Anterior Cervical Interbody Fusion Cage system is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MONET™ Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. MONET™ Anterior Cervical Interbody Fusion Cage system is to be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

The MONET™ Anterior Cervical Interbody Fusion Cage system is intended for use as an Interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of either PEEK with tantalum markers or titanium allov.

AI/ML Overview

This document does not contain information about an AI/ML powered device, thus the standard acceptance criteria and study information typically requested for such devices are not applicable.

The MONET™ Anterior Cervical Interbody Fusion Cage System is a medical device for spinal fusion, and its acceptance criteria and study data are based on mechanical and material equivalence rather than AI performance.

Therefore, many of the requested fields (e.g., sample size for test/training set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types) are not relevant to this medical device filing.

Here's the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance (Results)
ASTM F2077 (2014)	Results demonstrated that the performance of the subject device was equivalent to the predicate devices for: a. Static and Dynamic Axial Compression b. Static and Dynamic Compression-Shear c. Static and Dynamic Torsion
ASTM F2267 (2013)	Results demonstrated that the performance of the subject device was equivalent to the predicate devices for: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Static Push-out Test	Results demonstrated that the performance of the subject device was equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical testing. The testing was conducted on samples of the MONET™ Anterior Cervical Interbody Fusion Cage System itself, not patient data. The provenance is the device manufacturer's testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not expert medical consensus.

4. Adjudication method for the test set: Not applicable. Mechanical test results are measured values, not subject to medical adjudication.

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: Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used: For mechanical tests, the "ground truth" is defined by the physical properties and performance characteristics as measured against established engineering standards (ASTM F2077, ASTM F2267). The comparison is against the performance of a predicate device.

8. The sample size for the training set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

Study Proving Acceptance Criteria are Met:

The study proving the device meets the acceptance criteria is a series of mechanical and material performance tests. These tests were conducted according to established ASTM (American Society for Testing and Materials) standards.

Tests Performed:
- ASTM F2077: Test Methods for Intervertebral Body Fusion Devices. This standard includes:
  - Static and Dynamic Axial Compression
  - Static and Dynamic Compression-Shear
  - Static and Dynamic Torsion
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
- Static Push-out Test
Conclusion of the Study: The results from these tests "demonstrated that the performance of the subject device was equivalent to the predicate devices." This equivalence, along with similar intended uses, indications, technological characteristics, and principles of operation, led to the determination of Substantial Equivalence to the predicate devices (MATISSE™ Anterior Cervical Interbody Fusion Cage System, K162682 and K121569). The minor technological differences did not raise new issues of safety or effectiveness.

Summary

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June 25, 2018

CTL Medical Corporation % Mr. Michael A. Patz Senior Regulatory/Clinical Consultant ROMIS. Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K172788

Trade/Device Name: MONET™ Anterior Cervical Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 16, 2018 Received: May 21, 2018

Dear Mr. Patz:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172788

Device Name

MONETTM Anterior Cervical Interbody Fusion Cage System

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

CTL Medical Corporation's MONET™ ACIF Cage

Submitter:	CTL Medical CorporationTosan Onosode4550 Excel Parkway, Suite 300Addison, TX 75001Phone: 214-545-5820Fax: 888-831-4892
Contact Person:	Michael A. PatzRQMIS, Inc.110 Haverhill Road, Suite 526Amesbury, MA 01913Phone: 978-358-7307
Date Prepared:	April 16, 2018
Name of Device:	MONET™ Anterior Cervical Interbody Fusion Cage System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Sec 888.3080-Intervertebral Body Fusion DeviceProduct Code: ODP

Predicate Device:

Primary Predicate: K121569, MATISSE™ Anterior Cervical Interbody Fusion Cage System

Additional Predicate: K162682, MATISSE™ Anterior Cervical Interbody Fusion Cage System

Indications for Use:

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be used with supplemental fixation systems that have been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description:

Technological Characteristics:

The MONET™ Anterior Cervical Interbody Fusion Cage System are manufactured from either PEEK with tantalum markers or titanium alloy, which are the identical materials used to manufacture the predicates. All heights, and widths are within range covered by its predicate device.

Performance Data:

The MONET™ Anterior Cervical Interbody Fusion Cage System was tested per:

1. ASTM F2077: Test Methods for Intervertebral Body Fusion Devices. (2014)
- a. Static and Dynamic Axial Compression
- b. Static and Dynamic Compression-Shear
- c. Static and Dynamic Torsion
1. ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. (2013)
1. Static Push-out Test

Results demonstrated that the performance of the subject device was equivalent to the predicate devices.

Substantial Equivalence:

The MONET™ Anterior Cervical Interbody Fusion Cage System is as safe and effective as the predicate MATISSE™ Anterior Cervical Interbody Fusion Cage System, Titanium and PEEK (K162682 and K121569). The MONET™ Anterior Cervical Interbody Fusion Cage System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor

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technological differences between the MONET™ Anterior Cervical Interbody Fusion Cage System and its predicate device raise no new issues of safety or effectiveness. Thus, the MONET™ Anterior Cervical Interbody Fusion Cage System is substantially equivalent.

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.