# K040482: Ebi Esl Spine Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Apr 16, 2004 after 51 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K841189 (1984). 8 ancestors in all.
1,621 later devices descend from it; 3 cite it directly.
1 of 1,630 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020887: Ebi Ais Spine System, Ebi, L.P. (2002) Summary page 1.
- K024364: Synthes Vertebral Spacer TI (Curved and Narrow), Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K042268: Ebi Cas Spine Spacer System (2004), 1,620 descendants of its own
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) (2005), 1,571 descendants of its own
- K042930: Spacevision Cage System (2004), 1,440 descendants of its own
- K062759: Paramount VBR System (2007), 1,406 descendants of its own
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own

## Indications for use
The EBI ESL Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI ESL Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI ESL Spine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System or the EBI SpineLink II Spinal System.

Source page: https://510kreport.com/device/K040482
Methodology: https://510kreport.com/methodology