# K042772: Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Dec 13, 2004 after 69 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
Longest line of descent: 2 generations back to K964159 (1997). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033312: Ebi Top Loading Mas Spinal Fixation System, Ebi, L.P. (2004) Summary page 1.
- K012516: Ebi Spinelink - II Spinal Fixation System, Ebi, L.P. (2001) Summary page 4.
- K031355: Ebi Spinelink - II Spinal Fixation System, Ebi, L.P. (2003) Summary page 4.

## Most influential descendants
- K070530: Modification to Passmed Spinal System (2007), 2 descendants of its own
- K190376: PASS LP Spinal System (2019), 1 descendant of its own
- K213281: PASS LP™ Spinal System, CD Horizon™ Spinal System (2022), 0 descendants of its own

## Indications for use
The EBI® Array™ Spinal Fixation 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), spondytolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion. The EBI® VuePASS™ Portal Access System when used with the EBI® Array™ Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The EBI® SpineLink H1 Spinal Fixation 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), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion. The EBI® VuePASS™ Portal Access System when used with the EBI® SpineLink® II Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Source page: https://510kreport.com/device/K042772
Methodology: https://510kreport.com/methodology