(128 days)
The Fortilink-A Ti is indicated for anterior 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 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. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior FDA cleared supplemental fixation.
The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as 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 radios), 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 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-L Ti is indicated for lateral 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 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.
The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment. The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer.
The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as 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. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
The Fortilink-TC Ti is indicated for transforaminal 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 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.
The Fortilink-TS Ti 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 with an interbody fusion device.
The purpose of this Traditional 510(k) is to seek marketing clearance for the Fortilink Cages with TiPlus Technology. The Fortilink Cages with TiPlus Technology are used to restore intervertebral height and to facilitate intervertebral body fusion in the spine using various surgical approaches with autogenous bone graft and/or allogenic bone graft materials. The Fortilink Cages with TiPlus Technology are intended to be used from on various spinal sections, depending on the cage. These devices can used with and without supplemental fixation (see Section 11). The Fortilink Cages with TiPlus Technology are made from Ti-6Al-4V ELI (ASTM F3001) by an additive manufacturing process. The design contains solid structures and porous structures. The hollow geometry of the implants allows the cage to be packed with autogenous and/or allogenic bone graft.
This is a premarket notification for a medical device called "Fortilink Cages with TiPlus Technology," which are intervertebral body fusion devices. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical performance metrics with acceptance criteria, as would be typical for a novel AI/ML device or a device requiring clinical efficacy studies.
Therefore, the provided document does not contain the requested information regarding acceptance criteria, reported device performance (in a quantifiable manner for clinical outcomes), sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details, because these types of studies are generally not required for devices seeking 510(k) clearance by demonstrating substantial equivalence, especially for implantable mechanical devices like these.
Instead, the submission demonstrates substantial equivalence based on:
- Indications for Use: The Fortilink Cages (various models: Fortilink-C Ti, Fortilink-SC Ti, Fortilink-TS Ti, Fortilink-TC Ti, Fortilink-L Ti, Fortilink-A Ti, Fortilink-SA Ti) have intended uses that are similar to the predicate devices for spinal fusion in various regions (cervical, lumbar) for conditions like degenerative disc disease, spondylolisthesis, instability, trauma, and deformity.
- Technological Characteristics: The subject device is made from Ti-6Al-4V ELI (ASTM F3001) using an additive manufacturing process (Selective Laser Melting - SLM) to create solid and porous structures, similar to the primary predicate, the EIT Cellular Titanium Cage series. Both allow for bone graft packing.
- Performance Testing: The document mentions mechanical testing (per ASTM F2077 and ASTM F2267 for static compression, shear, torsion, dynamic tests, expulsion, and subsidence), biocompatibility testing (per ISO 10993), and MRI Safety Testing (per ASTM F2503-13, ASTM F2052-15, ASTM F2213-17, ASTM F2182-19e2, and ASTM F2119-07 (2013)). These tests confirm that the device performs mechanically and safely as expected for its class, similar to predicate devices.
Summary of missing information based on the request due to the nature of the 510(k) submission for this type of device:
- 1. Table of acceptance criteria and reported device performance: Not provided in the context of clinical performance metrics. Mechanical and biocompatibility test results are implicitly deemed acceptable if they meet the standards referenced, but specific numerical criteria and results are not detailed in this summary.
- 2. Sample size and data provenance for test set: Not applicable for this type of submission focused on substantial equivalence through material and mechanical testing. No patient-level test set data is mentioned.
- 3. Number of experts and qualifications for ground truth: Not applicable. Ground truth for mechanical devices usually refers to established engineering standards or successful predicate device performance.
- 4. Adjudication method: Not applicable.
- 5. MRMC comparative effectiveness study: Not done. This is not an AI-assisted diagnostic device.
- 6. Standalone performance (algorithm only): Not applicable. This is a physical implant, not an algorithm.
- 7. Type of ground truth used: For mechanical and material properties, the ground truth is established industry standards (ASTM, ISO) and the performance of legally marketed predicate devices.
- 8. Sample size for the training set: Not applicable. This is a manufactured medical device, not an AI/ML algorithm requiring a training set.
- 9. How ground truth for the training set was established: Not applicable.
§ 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.