# K062810: Solitaire Anterior Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Oct 17, 2006 after 28 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
No predicates in its family tree.
835 later devices descend from it; 2 cite it directly.
1 of 836 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Interpore Cross International Anterior Fixation Device (AFD): named in the summary without a submission number
- (no number) Interpore Cross International Expandable PEEK VBR System: named in the summary without a submission number
- (no number) EBI ESL Spine Spacer System: named in the summary without a submission number

## Most influential descendants
- K081501: Solitaire Anterior Spinal System (2008), 834 descendants of its own
- 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

## Indications for use
The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., TIO to LS) 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 neugal 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.

Source page: https://510kreport.com/device/K062810
Methodology: https://510kreport.com/methodology