# K111983: Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular Metal Technology
- Decided: Nov 18, 2011 after 129 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: 8 generations back to K010530 (2001). 24 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070382: Vista -S Device, Zimmer Trabecular Metal Technology (2007) Summary page 2.
- K092336: C-Thru Spinal System, Ebi, L.P. (2009) Summary page 2.
- K082848: Nubic and Rabea Devices, Signus Medizintechnik GmbH (2009) Summary page 2.
- K103033: Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx and 08-100-Xxxxx, Zimmer Trabecular Metal Technology (2011) Summary page 2.
- K061155: Vista P Vertebral Body Replacement System, Zimmer Trabecular (2006) Summary page 2.

## Most influential descendants
- K133784: Vista-S Device, Associated Instrumentation (2014), 29 descendants of its own
- K143297: Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (2015), 19 descendants of its own
- K162986: SPIRA Open Matrix ALIF (2017), 11 descendants of its own
- K180724: SPIRA Open Matrix LLIF (2018), 10 descendants of its own
- K190483: SPIRA Open Matrix ALIF and LLIF (2019), 9 descendants of its own

## Indications for use
The Vista®-S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-TI. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista®-S Device is implanted via an anterior approach. The Vista®-S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista®-s Device is intended for use with supplemental internal spinal fixation systems. The Vista®-S Device may be used with bone graft.

Source page: https://510kreport.com/device/K111983
Methodology: https://510kreport.com/methodology