# K161485: Nanovis Intervertebral Body Fusion System and Forticore (R)

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis, LLC
- Decided: Sep 6, 2016 after 98 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: 15 generations back to K003155 (2001). 116 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 122 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110442: Nanovis Intervertebral Body Fusion System, Nanovis, LLC (2011) Summary page 6.
- K140280: Forticore, Nanovis, LLC (2014) Summary page 6.
- K133614: Aleutian Ibf System, K2m, Inc. (2014) Summary page 6.

## Most influential descendants
- K171312: FortiCore® (2018), 3 descendants of its own
- 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
- K173832: InTice™-C Porous Ti Cervical Interbody System (2018), 0 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures. When used as a lumbar intervertebral body fusion device, the Nanovis Intervertebral Body Fusion System 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 I spondylolisthesis or retrolisthesis at the involved spinal level(s). Nanovis Intervertebral Body Fusion System implants are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures. When used as a cervical intervertebral body fusion device, FortiCore® is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one spinal level from C2-T1. These patients should have had at least six weeks of non-operative treatment. FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for cervical fusion procedures. When used as a lumbar intervertebral body fusion device, 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). FortiCore® devices are to be used with autogenous bone graft and in combination with supplemental fixation indicated for lumbar spinal fusion procedures.

Source page: https://510kreport.com/device/K161485
Methodology: https://510kreport.com/methodology