# K081880: Atlas Spine Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, Inc.
- Decided: Oct 2, 2008 after 92 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 8 generations back to K841189 (1984). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063464: Atlas Spine Vertebral Body Replacement, Atlas Spine, Inc. (2007) Summary page 1.
- K072226: Impix Spacer, Medicrea Technologies (2007) Summary page 1.

## Indications for use
Intervertebral Body Fusion Device: The Atlas Spine Spacer is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level from C3-C7. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Atlas Spine Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). This device is to be used with autogenous bone graft. The Atlas Spine Spacer is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. Vertebral Body Replacement: When used as a vertebral body replacement, the Atlas Spine Spacer is intended for use in the thoracolumbar spine (T1-L5) for partial or complete replacement (i.e., vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Atlas Spine Spacer is also indicated for treating fractures of the thoracic and lumbar spine. The Atlas Spine Spacer is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The interior of the Atlas Spine Spacer can be packed with bone. This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lmnbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

Source page: https://510kreport.com/device/K081880
Methodology: https://510kreport.com/methodology