# K122588: Vusion CS Plus

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Jun 12, 2013 after 292 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: 12 generations back to K003155 (2001). 73 ancestors in all.
206 later devices descend from it; 2 cite it directly.
0 of 280 devices in its family (counting itself) have 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 1.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 1.
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009) Summary page 1.
- K113138: Aleutian System, K2m, Inc. (2012) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.

## Most influential descendants
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages (2017), 199 descendants of its own
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages (2017), 159 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own
- K183447: EIT Cellular Titanium Lumbar Cage - T/PLIF (2019), 131 descendants of its own
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (2020), 130 descendants of its own

## Indications for use
The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K122588
Methodology: https://510kreport.com/methodology