# K111965: Vusion (R) OS

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development
- Decided: Oct 25, 2011 after 106 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: 9 generations back to K841189 (1984). 19 ancestors in all.
No later device cites it as a predicate yet.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062666: Vusion TS, PS, and CS Partial Vertebral Body Replacements, Ortho Development Corp. (2007) Summary page 1.
- K082712: Theken Spine VU Epod and VU Lpod System, Theken Spine, LLC (2009) Summary page 1.
- K073202: Ardis Spacer, Abbott Spine, Inc. (2008) Summary page 1.

## Indications for use
Vusion OS is indicated for use as an interbody fusion device at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Vusion OS is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment.

Source page: https://510kreport.com/device/K111965
Methodology: https://510kreport.com/methodology