(283 days)
Not Found
No
The summary describes a physical implant (cage) and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to treat degenerative disc disease (DDD) of the cervical spine by facilitating intervertebral body fusion, which directly addresses a medical condition to restore function.
No
The device description clearly states it is an "Interbody fusion cage device to maintain cervical intervertebral spacing and must be used with supplemental fixation," indicating it is a therapeutic implant for fusion, not a diagnostic tool.
No
The device description explicitly states the device is a physical implant made of PEEK or titanium alloy, and the performance studies involve mechanical testing of this physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the MONET™ Anterior Cervical Interbody Fusion Cage system is an "Interbody fusion cage device" intended for surgical implantation in the cervical spine.
- Intended Use: The intended use is to facilitate intervertebral body fusion in the cervical spine, which is a surgical procedure, not an in vitro test.
The information provided describes a surgically implanted medical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
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 prior to treatment with an intervertebral cage.
Product codes
ODP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at the C2 to C7 disc levels
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MONET™ Anterior Cervical Interbody Fusion Cage System was tested per:
- 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 - ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. (2013)
- Static Push-out Test
Results demonstrated that the performance of the subject device was equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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)
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.
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
CTL Medical Corporation's MONET™ ACIF Cage
| Submitter: | CTL Medical Corporation
Tosan Onosode
4550 Excel Parkway, Suite 300
Addison, TX 75001
Phone: 214-545-5820
Fax: 888-831-4892 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael A. Patz
RQMIS, Inc.
110 Haverhill Road, Suite 526
Amesbury, MA 01913
Phone: 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 Device
Product 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:
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
4
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:
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.
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:
-
- 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
-
- ASTM F2267: Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. (2013)
-
- 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.