(64 days)
No
The 510(k) summary describes a physical medical device (an interbody fusion cage and plate) and its mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms to facilitate intervertebral body fusion. This directly addresses and treats a medical condition.
No
Explanation: The device is an interbody fusion cage system used for treatment (facilitating intervertebral body fusion), not for diagnosing medical conditions.
No
The device description explicitly states it consists of a plate and bone anchoring screws made of titanium alloy, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate intervertebral body fusion in the cervical spine. This is a therapeutic and structural device, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a plate and bone anchoring screws made of titanium alloy, designed for implantation. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly 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. The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. If the MONET Anterior Cervical Interbody Fusion Cage System is used without the Supplementary Fixation Plate assembly, note that supplementary fixation is still required.
Product codes
OVE, ODP
Device Description
The subject device consists of a plate and bone anchoring screws which are made of titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. The anterior fixation plates can only be assembled with the predicate K172788 cage prior to final use. The final assembly constructs are implanted using a combination of device specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is considered an enhanced and modular line-extension to already cleared MONET™ Anterior Cervical Interbody Fusion Cage System (K172788).
The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate have the same risk classification, intended use, and generic designation, as the predicate system the MONET™ Anterior Cervical Interbody Fusion Cage System (K172788). The system is offered in various sizes and configurations to accommodate anatomical variation in the cervical vertebral levels and/or patient anatomy.
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
Not Found
Summary of Performance Studies
The following test were performed per ASTM F2077:
- Static Compression
- Static Compression Shear
- Static Torsion
- Dynamic Axial Compression
- Dynamic Torsion
In addition, the following tests were performed.
- Plate Pull-Off
- Screw Push out
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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October 11, 2018
CTL Medical Corporation % Mr. Barry E. Sands President and Founder ROMIS. Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913
Re: K182151
Trade/Device Name: MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: August 1, 2018 Received: August 8, 2018
Dear Mr. Sands:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Melissa Hall -S
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) K182151
Device Name
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
Indications for Use (Describe)
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly 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. The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. If the MONET Anterior Cervical Interbody Fusion is used without the Supplementary Fixation Plate assembly, note that supplementary fixation is still required.
Type of Use (Select one or both, as applicable)X 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 with Supplementary Fixation Plate
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
CTL Medical Corporation Andrea Wilcox 4550 Excel Parkway Site 300 Addison, TX 75001 Phone: 214-545-5820 Fax: 888-831-4892
Contact Person: Mr. Barry E Sands President RQMIS Inc. 110 Haverhill Rd., Suite 526 Amesbury, MA 01913 Phone: 978-358-7307 Facsimile: 978-447-0206 Email: barrysands@rqmis.com
Date Prepared: July 30, 2018
Name of Device and Name/Address of Sponsor
Trade Name: MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate CTL Medical Corporation 4550 Excel Parkway Site 300 Addison, TX 75001
Common or Usual Name
Intervertebral Body Fusion Device
Classification Name
21 CFR 888.3080 Intervertebral Body Fusion Device, Cervical
Product Codes: ODP, OVE
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Predicate Devices
Primary:
K172788, MONET™ Anterior Cervical Interbody Fusion Cage System Additional:
K121569, MATISSE™ Anterior Cervical Interbody Fusion Cage System K162682, MATISSE™ Anterior Cervical Interbody Fusion Cage System
Intended Use / Indications for Use
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly 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. The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly is used to facilitate intervertebral body fusion in the cervical spine at the C2 to C7 disc levels using autograft bone. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. If the MONET Anterior Cervical Interbody Fusion Cage System is used without the Supplementary Fixation Plate assembly, note that supplementary fixation is still required.
Device Description
The subject device consists of a plate and bone anchoring screws which are made of titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. The anterior fixation plates can only be assembled with the predicate K172788 cage prior to final use. The final assembly constructs are implanted using a combination of device specific and universal instruments manufactured from stainless steel materials that conform to ASTM F899.
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is considered an enhanced and modular line-extension to already cleared MONET™ Anterior Cervical Interbody Fusion Cage System (K172788).
The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate have the same risk classification, intended use, and generic designation, as the predicate system the MONET™ Anterior Cervical Interbody Fusion Cage System (K172788). The system is offered in various sizes and configurations to accommodate anatomical variation in the cervical vertebral levels and/or patient anatomy.
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Technological Characteristics
MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate assembly consists of two modular components: The first component is the previously cleared K172788, the MONET™ Anterior Cervical Interbody Fusion Cage and the second component is the complimentary reinforcement hardware.
MONET™ ACIF cage and the supplementary fixation plate are mechanically held together by the C-shaped "attachment arms" that mate with the "waist tracks". The Cshaped mating features provide additional stability to the MONET™ ACIF cage by increasing the footprint of the device within the disc space.
When fully assembled, the MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate provides mechanical support/stability to cervical spine segment to allow for bony fusion to occur.
Material Composition
The subject supplementary fixation plate hardware (modular disc plates and bone anchoring screws) are made of the same implantable grade titanium alloy (Ti-6Al-4V, ASTM F136).
All subject instruments that are included as part of this submission and comes in contact with human tissue are manufactured from stainless steel materials. Instrument handles that will never touch human tissue are manufactured from stainless steel and silicone.
Performance Data
The following test were performed per ASTM F2077:
- Static Compression .
- Static Compression Shear
- Static Torsion
- Dynamic Axial Compression ●
- Dynamic Torsion
In addition, the following tests were performed.
- Plate Pull-Off
- . Screw Push out
Substantial Equivalence
The MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is as safe and effective as the predicate MONET™ and MATISSE™
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Anterior Cervical Interbody Fusion Cage System, Titanium and PEEK (K172788, 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 reinforcement related technological differences between the MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate and its predicate device do not raise different questions of safety or effectiveness. Thus, the MONET™ Anterior Cervical Interbody Fusion Cage System is substantially equivalent.