(87 days)
The Fortilink-C with TiPlus Technology is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
The Fortilink-TS with TiPlus Technology is indicated for transforaminal and posterior interbody fusion (IBF) 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 L2 to 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 FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.
The Fortilink-TC with TiPlus Technology is indicated for transforaminal interbody fusion (IBF) of the spine in sketally mature patients with degenerative disc disease (DD) 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 are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment with an interbody fusion device.
Fortilink with TiPlus Technology are implantable interbody fusion devices intended for use in the cervical and the lumbar spine. The subject device inserters are device specific accessories to be utilized during the procedure to insert the TiPlus Interbody devices into the disc space.
The provided text is a 510(k) summary for a medical device called "Fortilink with TiPlus Technology," which are intervertebral body fusion devices. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria in a clinical or analytical context like an AI/ML device.
Therefore, the requested information regarding acceptance criteria, study details, ground truth, sample sizes, and expert adjudication (which are typical for AI/ML device performance studies) is not applicable or present in this document.
The document primarily compares the subject device to predicate devices based on attributes like:
- Indications for Use: The subject device's indications are equivalent to the predicate devices.
- Regulations, Product Code & Class: Identical to predicates.
- Instrument Type: Identical to predicates (Orthopedic Manual Surgical Instrument - interbody inserter).
- Biocompatibility Patient Contact Duration: Identical to predicates (Limited, ≤24 hours).
- Surgical Approach: Identical to predicates (Anterior cervical, Posterior lumbar).
- Footprint: Identical to predicates.
- Sterility: Identical to predicates (Non-Sterile devices provided with validated steam sterilization parameters to assure a SAL 10-6).
- Reusable/Single Use: Identical to predicates (Instruments are reusable).
The document mentions "Engineering analysis and bench top testing of the inserters" which demonstrated that modified designs do not present different issues of safety and effectiveness than the predicates. However, it does not provide specific acceptance criteria or performance metrics from these tests. These are likely mechanical tests related to the physical integrity and function of the inserters, not a study of clinical utility or diagnostic accuracy.
§ 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.