When the Fortlink-A is used as a lumbar interbody fusion (IBF) implant, it is 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. This IBF device is 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 device is intended to be used with supplemental fixation cleared for the implanted level. Patients should have at least six (6) months of non-operative treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
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 nonoperative 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. These implants are manufactured from a radiolucent polymer (PolyEtherKetone (PEKK)) (ASTM F2820) which should support radiographic imaging inside the implant to evaluate fusion status and are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant position. The implant is provided sterile by gamma irradiation and is intended to be used with supplemental fixation cleared for the implanted level. The implant is supplied with instrumentation necessary to facilitate the insertion and removal of the implant, as well as qeneral manual surqical instruments.
The implant is provided in different footpring heights to provide implant options best suited to an individual's pathology and anatomical condition.
This document is a 510(k) Pre-market Notification for the Fortilink® Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology. It seeks clearance for an additional design, the Fortilink-A, and MR Conditional labeling for the entire Fortilink family. The document establishes substantial equivalence to predicate devices based on technological characteristics and performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Device Performance (as reported) |
|---|---|
| Static and Dynamic Torsion Testing | Performed on the worst-case construct of the predicate family, conforming to ASTM F2077-18. Performance is not explicitly detailed but stated to demonstrate substantial equivalence. |
| Static and Dynamic Axial Compression Testing | Performed on the worst-case construct of the predicate family, conforming to ASTM F2077-18. Performance is not explicitly detailed but stated to demonstrate substantial equivalence. |
| Subsidence Testing | Performed on the worst-case construct of the predicate family, conforming to ASTM F2267-04 (2018). Performance is not explicitly detailed but stated to demonstrate substantial equivalence. |
| Expulsion Testing | Performed on the worst-case construct of the predicate family, conforming to DRAFT Z8423Z. Performance is not explicitly detailed but stated to demonstrate substantial equivalence. |
| MR Safety: Magnetically Induced Displacement Force | Tested in accordance with ASTM F2052-15. Device is determined to be MR Conditional. |
| MR Safety: Magnetically Induced Torque | Tested in accordance with ASTM F2213-17. Device is determined to be MR Conditional. |
| MR Safety: Radio Frequency Induced Heating | Tested in accordance with ASTM F2182-11a and FDA Guidance. Device is determined to be MR Conditional. |
| MR Safety: MR Image Artifacts | Tested in accordance with ASTM F2119-07 (Reapproved 2013). Device is determined to be MR Conditional. |
| Inserter Instruments: Insertion/Removal & Reusability | Evaluated to demonstrate no different issues of safety and effectiveness than predicates. Performance is not explicitly detailed. |
Study Providing Evidence of Meeting Acceptance Criteria:
The study described in this document is a non-clinical performance testing study, primarily focusing on mechanical testing and MR Safety testing for the Fortilink® Interbody Fusion Device (IBF) with TETRAfuse® 3D Technology, specifically focusing on the addition of the Fortilink-A design and MR Conditional labeling.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Mechanical Testing: The document states that the "worst-case construct for the predicate family of Fortilink devices" was assessed. It does not provide a specific numerical sample size (e.g., number of devices tested for each mechanical test).
- Data Provenance: The data is generated from non-clinical (bench) testing performed by the manufacturer, Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. The country of origin of the data is not explicitly stated beyond the manufacturer's location in Marquette, Michigan, USA. This is a prospective test in the sense that the testing was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. For mechanical and MR safety testing, "ground truth" is established by adherence to recognized ASTM standards and FDA guidance documents. The expertise lies in the engineers and technicians performing the tests and interpreting the results according to these standardized methodologies, rather than clinical experts establishing a ground truth based on patient data.
4. Adjudication Method for the Test Set
This information is not applicable to the non-clinical testing performed. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image interpretation studies where multiple human readers assess a case.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This submission concerns an interbody fusion device, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is an implanted medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing and MR Safety testing, the "ground truth" is defined by:
- Recognized consensus standards: Specifically, the ASTM standards (F2077-18, F2267-04 (2018), F2052-15, F2213-17, F2182-11a, F2119-07 (Reapproved 2013)) and the DRAFT Z8423Z standard for expulsion testing.
- FDA Guidance: "Guidance for Industry and Food and Drug Administration Staff, Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices."
The device's performance is compared against the requirements and specifications outlined in these documents to demonstrate compliance.
8. The Sample Size for the Training Set
This information is not applicable. This is a hardware medical device submission, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 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.