# K061563: Ebi Array Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Jun 23, 2006 after 18 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
275 later devices descend from it; 5 cite it directly.
0 of 276 devices in its family (counting itself) have 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) EBI® Array® Spinal Fixation System (formerly referred to as 'Top Loading MAS Spinal Fixation System'): named in the summary without a submission number
- (no number) EBI® Webb Morley Spine System: named in the summary without a submission number
- (no number) Interpore Cross International Synergy Spinal System (Posterior): named in the summary without a submission number
- (no number) Interpore Cross International Synergy Spinal System (Anterior): named in the summary without a submission number

## Most influential descendants
- K081952: Synergy Spinal System (6.35 Polaris) (2008), 255 descendants of its own
- K090523: Polaris Spinal System (2009), 156 descendants of its own
- K090203: 5.5 Helical Flange Spinal System, Polaris Components (2009), 154 descendants of its own
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System (2010), 144 descendants of its own

## Indications for use
The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K061563
Methodology: https://510kreport.com/methodology