# K031355: Ebi Spinelink - II Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 22, 2003 after 84 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: 1 generation back to K964159 (1997). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013887: Bacfix Spinal Fixation System, Spinal Concepts, Inc. (2002)
- K964159: CD Spinal System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K983706: Modification of Townley Pedicle Screw Plating System, Sofamor Danek USA,Inc. (1998) Summary page 1.

## Most influential descendants
- K042772: Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device (2004), 3 descendants of its own
- 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@SpineLink@I1 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacraViliac 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 or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anteriodanterolateral fixation.

Source page: https://510kreport.com/device/K031355
Methodology: https://510kreport.com/methodology