# K091406: Atlas Spine Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Atlas Spine, LLC
- Decided: Sep 4, 2009 after 115 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063205 (2007). 2 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K063205: Atlas Spine Vertebral Body Replacement, Atlas Spine, LLC (2007) Summary page 1.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 1.

## Most influential descendants
- K100743: Atlas Spine Pivoting System (2010), 4 descendants of its own
- K172419: Velofix™ TLIF Cage (2017), 2 descendants of its own
- K181829: Velofix TLIF Cage (2018), 1 descendant of its own
- K243816: Testa TP Pivoting Spacer System (2025), 0 descendants of its own
- K183243: Velofix TLIF Cage (2019), 0 descendants of its own

## Recalls of this device
- Jul 26, 2013 · Class II · Z-1616-2016: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

## Indications for use
Intervertebral Body Fusion Device: 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 I 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 autograft and/or allograft. The device must be used with supplemental internal fixation systems cleared for the conditions listed above (i.e., tumor or trauma of T1-L5).

Source page: https://510kreport.com/device/K091406
Methodology: https://510kreport.com/methodology