(64 days)
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.
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.
The provided text is a 510(k) summary for the MONET™ Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate. It describes the device, its intended use, and its substantial equivalence to predicate devices based on performance data.
However, the document does not contain information related to software or AI-based devices. Therefore, it does not include details about acceptance criteria, reported device performance in a clinical study involving AI, sample sizes for AI model validation, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth establishment, or training set details.
The performance data mentioned in the document refers to biomechanical tests performed on the physical medical device (in-vitro mechanical tests), not a study of an AI algorithm or software. The tests performed are:
- Static Compression
- Static Compression Shear
- Static Torsion
- Dynamic Axial Compression
- Dynamic Torsion
- Plate Pull-Off
- Screw Push out
These tests were performed according to ASTM F2077 and assess the mechanical integrity and stability of the intervertebral fusion cage system.
§ 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.