# K191822: Nano FortiCore, FortiCore

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis, LLC
- Decided: Oct 11, 2019 after 95 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K841189 (1984). 239 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 242 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171312: FortiCore®, Nanovis, LLC (2018) Summary page 6.
- K140280: Forticore, Nanovis, LLC (2014) Summary page 6.
- K160874: Nanovis Intervertebral Body Fusion System and FortiCore®, Nanovis, LLC (2016) Summary page 6.
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R), Nanovis, LLC (2016) Summary page 6.
- K110442: Nanovis Intervertebral Body Fusion System, Nanovis, LLC (2011) Summary page 6.
- K173324: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2018) Summary page 6.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 6.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 6.

## Most influential descendants
- K241605: Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System with Nanotechnology (2024), 0 descendants of its own
- K230936: Anatomic PEEK™ Cervical Fusion System with Nanotechnology (2023), 0 descendants of its own

## Indications for use
FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® cervical devices are intended for anterior cervical spinal fusion procedures in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at multiple contiguous levels from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nano FortiCore® cervical devices are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation indicated for cervical fusion procedures. Nano FortiCore® lumbar devices are intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) at one or two contiguous spinal levels from L2-S1. These patients should have had six months of nonoperative treatment. These patients may have had a previous non-fusion spinal surgery and/or may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). Additionally, Nano FortiCore® lumbar devices can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. Nano FortiCore® lumbar devices are to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation indicated for lumbar spinal fusion procedures.

Source page: https://510kreport.com/device/K191822
Methodology: https://510kreport.com/methodology