# K091638: Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031

- Pathway: 510(k) (Abbreviated)
- Applicant: Spinefrontier, Inc.
- Decided: Sep 14, 2009 after 102 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: 2 generations back to P950002 (1996). 3 ancestors in all.
15 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072289: Spinefrontier Dorado VBR, Spinefrontier, Inc. (2007) Summary page 1.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999)

## Most influential descendants
- K111553: Spinefrontier Lumbar Ibf System (2011), 14 descendants of its own
- K160976: Altus Spine Interbody Fusion System (2017), 8 descendants of its own
- K170512: Altus Spine Titanium Interbody Fusion System (2017), 6 descendants of its own
- K142504: SpineFrontier Lumbar Interbody Fusion Device System (2015), 4 descendants of its own
- K201367: FlareHawk TiHawk9 Interbody Fusion System (2020), 2 descendants of its own

## Indications for use
The DORADO Wide Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO Wide Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K091638
Methodology: https://510kreport.com/methodology