# K081501: Solitaire Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Spine
- Decided: Jul 2, 2008 after 34 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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 K022143 (2003). 3 ancestors in all.
834 later devices descend from it; 5 cite it directly.
1 of 838 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071922: Interplate Interbody Fusion Device, Models C, CGC, L and LGC, Rsb Spine, LLC (2007) Summary page 2.
- K022143: Interpore Cross International Anterior Fixation Device (Afd), Interpore Cross Intl. (2003) Summary page 2.
- K062810: Solitaire Anterior Spinal System, Ebi, L.P. (2006) Summary page 2.

## Most influential descendants
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K123045: Brigade Standalone System (2013), 696 descendants of its own
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K140479: Coroent XL-F System (2014), 465 descendants of its own

## Recalls of this device
- Feb 12, 2016 · Class II · Z-1253-2016: Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.

## Indications for use
The Solitaire Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace 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 Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System 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. As an intervertebral body fusion device designed for use with autograft, the Solitaire Anterior Spinal System is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K081501
Methodology: https://510kreport.com/methodology