# K020887: Ebi Ais Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: May 16, 2002 after 59 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: 2 generations back to K841189 (1984). 5 ancestors in all.
1,622 later devices descend from it; 2 cite it directly.
1 of 1,628 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 1.
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K001340: Stackable Cage System, Depuyacromed (2000) Summary page 1.
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 1.
- K010530: Geo Structure, Interpore Cross Intl. (2001) Summary page 1.

## Most influential descendants
- K040482: Ebi Esl Spine Spacer System (2004), 1,621 descendants of its own
- 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

## Indications for use
The EBI AIS Spine 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 AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine 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 Omega 21 System or the EBI SpineLink System.

Source page: https://510kreport.com/device/K020887
Methodology: https://510kreport.com/methodology