# K092774: Atlas Intervertebral Body Cage

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Edge, LLC
- Decided: Feb 2, 2010 after 146 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: 7 generations back to K841189 (1984). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060916: Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017., Spinal Edge, LLC (2006) Summary page 1.
- K083815: Lanx Fusion System, Lanx, Inc. (2009) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.

## Indications for use
When used as vertebral body replacement, the ATLAS -Intervertebral Body Cage is indicated for use in the thoracolumbar spine (T I-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma. The ATLAS Intervertebral Body Cage is intended to be used. with supplemental fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) the interior spacer may be packed with bone graftingtmaterial. The ATLAS Intervertebral Body Cage has been designed to provide anterior column support even in the absence of fusion for a prolonged period of time. When used as a lumbar intervertebral body fusion device the ATLAS Intervertebral Body Cage is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature individuals with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 to SI. DDD is defined and discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s). The ATLAS Intervertebral Body Cage is implanted via an anterior or posterior approach and is combined with supplemental fixation. For either intended use, the ATLAS Intervertebral Body Cage must be used with supplemental internal fixation.

Source page: https://510kreport.com/device/K092774
Methodology: https://510kreport.com/methodology