(127 days)
When Fortilink®-C is used as cervical interbody fusion (IBF) implants, these devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the cervical spine and are placed via an anterior approach from C2-C3 to C7-T1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) weeks of non-operative treatment with an interbody fusion device.
When Fortilink®-TS and Fortilink®-L are used as lumbar interbody fusion (IBF) implants, these devices are indicated for intervertebral body fusion of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L1-L2 to L5-S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment prior to treatment with an interbody fusion device.
The Fortilink® interbody fusion (IBF) devices are designed to be inserted into the intervertebral body space of the spine, and are intended for intervertebral body fusion. The purpose of this 510(k) is to seek marketing clearance for modifications to the straight and angled inserter tools for the Fortilink®-L device. The modifications include the following:
Straight Inserter: Improve opening mechanism and disassembly prevention features
Angled Inserter:
- Apply an offset and angle to the inserter handle to align it with the Fortilink®-L . implant
- Apply the same design changes (improved opening mechanism and disassembly ● features) as applied for the straight inserter
This document describes a 510(k) premarket notification for the Fortilink® IBF System with TETRAfuse®3D Technology, specifically focusing on modifications to inserter tools. It does not contain information about a study proving the device meets acceptance criteria related to clinical performance, nor does it involve an AI/ML component.
Therefore, I cannot provide the requested information as the document *does not contain details about acceptance criteria or a study related to device performance in the context of clinical outcomes or AI/ML. *
The information present in the document pertains to:
- Device cleared: Fortilink® IBF System with TETRAfuse®3D Technology, with modified straight and angled inserter tools.
- Purpose of 510(k): Seeking marketing clearance for modifications to inserter tools, not for the underlying interbody fusion device's clinical efficacy or safety, which would have been established in previous clearances (referenced by K172343).
- Assessment of modifications: The substantial equivalence is based on engineering analysis and testing, including:
- Risk analysis
- Simulated insertion/removal testing
- Tissue blocking opening testing
- Reuse testing
- Stack-up of design drawings
- Acceptance Criteria for the Modifeid Inserter Tools: "All completed tests met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria for these engineering tests are not detailed in this summary.
- Type of Ground Truth: For the mechanical/engineering tests, the "ground truth" would be the successful completion of the tests according to design specifications and pre-determined mechanical/functional requirements. This is not clinical ground truth.
In summary, the provided document is a regulatory clearance letter and 510(k) summary for a device modification (inserter tools), not a clinical study report or performance evaluation of a device (especially not an AI/ML device) that would typically involve the detailed acceptance criteria and study information you've requested.
§ 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.