# K033312: Ebi Top Loading Mas Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jan 13, 2004 after 91 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
No predicates in its family tree.
277 later devices descend from it; 5 cite it directly.
0 of 278 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) Webb-Morley Spine System: named in the summary without a submission number
- (no number) EBI Omega21 Spinal Fixation Device: named in the summary without a submission number
- (no number) EBI P148 Spinal Fixation Devcie: named in the summary without a submission number
- (no number) Zielke VDS System: named in the summary without a submission number

## Most influential descendants
- K090523: Polaris Spinal System (2009), 156 descendants of its own
- K100220: Polaris Spinal System (2010), 153 descendants of its own
- K100409: Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System (2010), 144 descendants of its own
- K082187: Biomet Anterior Lumbar Plate (2008), 126 descendants of its own
- K121791: Zou Anterior Lumbar Plate System (2012), 113 descendants of its own

## Indications for use
The EBI® Top Loading MAS 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.

Source page: https://510kreport.com/device/K033312
Methodology: https://510kreport.com/methodology