# K100037: Advanced Vertebral Solutions Express BFD

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vertebral Solutions, LLC
- Decided: Sep 23, 2010 after 260 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072120: Paramount Intervertebral Body Fusion Device, Innovative Spinal Technologies, Inc. (2007) Summary page 1.
- K072970: Patriot Spacers, Globus Medical, Inc. (2008) Summary page 1.

## Indications for use
The Advanced Vertebral Solutions EXPRESS IBFD, when used with autologous bone graft, is indicated for use in patients wNith Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to SI. These DDD patients may also have up to Grade I spondvlolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Advanced Vertebral Solutions EXPRESS II3FD is to be implanted via a transforaminal approach. The device is to be used singly in the lunibosacral spine with supplemental posterior fixation.

Source page: https://510kreport.com/device/K100037
Methodology: https://510kreport.com/methodology