# K062685: Ebi Aray Spinal System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Oct 6, 2006 after 28 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K941367 (1994). 3 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061563: Ebi Array Spinal System, Ebi, L.P. (2006) Summary page 1.
- K033312: Ebi Top Loading Mas Spinal Fixation System, Ebi, L.P. (2004) Summary page 1.
- K941367: Webb-Morley Spine System, Electro-Biology, Inc. (1994) Summary page 1.

## Most influential descendants
- K073430: Valeo Pedicle Screw Spinal System (2008), 24 descendants of its own
- K080767: Conquest Spinal System (2008), 21 descendants of its own
- K123373: Nautilus Spinal System (2013), 17 descendants of its own
- K132760: Nautilus Spinal System (2013), 14 descendants of its own
- K141222: Nautilus Spinal System and Solstice Oct System (2015), 13 descendants of its own

## Recalls of this device
- Sep 16, 2010 · Not classified · Z-0131-2011: One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate tor

## 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/K062685
Methodology: https://510kreport.com/methodology