# K103369: Vault Alif System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal USA
- Decided: Apr 4, 2011 after 138 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 11 generations back to K841189 (1984). 44 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 2.
- K081501: Solitaire Anterior Spinal System, Biomet Spine (2008) Summary page 2.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 2.

## Most influential descendants
- K130445: Vault Alif System (2013), 9 descendants of its own
- K132596: Proposed Optimus (2014), 5 descendants of its own
- K200352: Axis Spine Technologies ALIF (2020), 2 descendants of its own
- K253559: Ventana™ A Anterior Lumbar Interbody System (2026), 0 descendants of its own
- K213118: Dakota ALIF System (2022), 0 descendants of its own

## Indications for use
The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenuos bone graft. Patients should have at least six months of non-operative trecatment prior to treatment with a lumbar intervertebral fusion device. The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.

Source page: https://510kreport.com/device/K103369
Methodology: https://510kreport.com/methodology