# K061978: Ebi, L.P.'S Line Extension to the Array Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Aug 11, 2006 after 29 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 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 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

## Most influential descendants
- K122332: Towerlox Pedicle Screw System (2012), 14 descendants of its own
- K131538: Caplox II Pedicle Screw System/Towerlox Pedicle Screw System (2013), 6 descendants of its own
- K152781: Adena-Zina System (2016), 5 descendants of its own
- K212066: Adena-Zina System (2021), 3 descendants of its own
- K151116: CapLOX II/TowerLOX Pedicle Screw System (2015), 3 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 sacralliliac 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, pseudarthirosis, and failed previous fusion.

Source page: https://510kreport.com/device/K061978
Methodology: https://510kreport.com/methodology