# K012516: Ebi Spinelink - II Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Nov 27, 2001 after 113 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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® SpineLink™ System: named in the summary without a submission number
- (no number) EBI® Omega 21™ System: named in the summary without a submission number
- (no number) Webb-Morley Spine System: named in the summary without a submission number

## 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™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system. When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar — first sacral (LS — S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.

Source page: https://510kreport.com/device/K012516
Methodology: https://510kreport.com/methodology