# K992920: Ebi Spinelink System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Nov 23, 1999 after 85 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.
4 later devices descend from it; 2 cite 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 Webb-Motley Spine System: named in the summary without a submission number

## Most influential descendants
- K133287: Presson Spinal Fixation System (2014), 1 descendant of its own
- K071990: Valeo Cervical Plate System (2007), 1 descendant of its own
- K160820: PressON Pro Spinal Fixation System (2016), 0 descendants of its own
- K082037: Seeplate Cervical Plate System (2008), 0 descendants of its own

## Indications for use
The EBI SpineLink™ System és a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacralf iliac screw fixcation system of the noncervical spine. 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 (psuedarthrosis). In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthests (Grades 3 and 4) of the fifth lumbar - first sacral (L5-51) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device Jfixced or attached to the lumbar and sacral spine (L3 and below); and (@) who are having the device removed after the development of a solid fusion mass. When used as a posterior hook and sacralf iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation 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 radiograpbic studies). Psuedarthrosis; stenosts; scoliosis; spondylolisthesis, Jracture; previous failed fusion; or tumor resection. When used as an anterior fixcation system, the levels of attachment are the anterolateral vertebral bodses of the lumbar and thoradic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic orygin with degeneration of the disc confirmed by history and radiggraphic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthests, fracture; previous fasled fusion; or tumor resection.

Source page: https://510kreport.com/device/K992920
Methodology: https://510kreport.com/methodology