# K110442: Nanovis Intervertebral Body Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Nanovis, LLC
- Decided: Nov 9, 2011 after 266 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: 13 generations back to K003155 (2001). 84 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 95 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 2.
- K081730: Novel Cervical Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 2.
- K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer, Choice Spine, Llp (2009) Summary page 2.
- K100214: Cornerstone PSR Cervical Interbody Fusion Device, Medtronic Sofamor Danek (2010) Summary page 2.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 2.
- K080537: L-Varlock, Kiscomedica S.A. (2008) Summary page 3.
- K080401: Shell Cage, Wave Cage, Loop Cage, Advanced Medical Technologies AG (2008) Summary page 3.
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 3.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 3.
- K080314: Spinal Usa Interbody Fusion Device, Spinal USA (2008) Summary page 3.
- K081196: Spinal Usa VBR System, Spinal USA (2008) Summary page 3.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 3.

## Most influential descendants
- K140280: Forticore (2014), 9 descendants of its own
- K161485: Nanovis Intervertebral Body Fusion System and Forticore (R) (2016), 5 descendants of its own
- K160874: Nanovis Intervertebral Body Fusion System and FortiCore® (2016), 4 descendants of its own
- K171312: FortiCore® (2018), 3 descendants of its own
- K191822: Nano FortiCore, FortiCore (2019), 2 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.

Source page: https://510kreport.com/device/K110442
Methodology: https://510kreport.com/methodology