# K171312: FortiCore®

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis, LLC
- Decided: Jan 22, 2018 after 263 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 20 generations back to K841189 (1984). 217 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 221 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R), Nanovis, LLC (2016) Summary page 4.
- K140280: Forticore, Nanovis, LLC (2014) Summary page 4.
- K160874: Nanovis Intervertebral Body Fusion System and FortiCore®, Nanovis, LLC (2016) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.
- K160125: Cascadia Interbody System, K2m (2016) Summary page 4.

## Most influential descendants
- K191822: Nano FortiCore, FortiCore (2019), 2 descendants of its own
- 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® is 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, FortiCore® can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. FortiCore® 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/K171312
Methodology: https://510kreport.com/methodology