# K060916: Atlas Spinal Cage, Models SC-150-007, 009, 011, 013, 015, 017.

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Edge, LLC
- Decided: Jun 8, 2006 after 65 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003275 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K092774: Atlas Intervertebral Body Cage (2010), 0 descendants of its own

## Indications for use
The Spinal Edge ATLAS Spinal Cage is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damage or unstable vertebral body due to tumor or trauma. The Spinal Edge ATLAS Spinal Cage is intended to be used with supplemental spinal fixation system 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 of the spacer may if indicated be packed with bone grafting material. The Spinal Edge ATLAS Spinal Cage is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period of time.

Source page: https://510kreport.com/device/K060916
Methodology: https://510kreport.com/methodology