# K983667: Ionics Levante Intervertebral Pillar, Expandable

- Pathway: 510(k) (Traditional)
- Applicant: Ionics Medical Corp.
- Decided: Jul 5, 2000 after 625 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081673: Dyn-Alif Anterolateral Intervertebral Body Fusion Device (2008), 0 descendants of its own

## Indications for use
The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L35) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation. To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures To facilitate anterior decompression of the spinal cord and neural structure To facilitate the reduction of kyphotic deformities

Source page: https://510kreport.com/device/K983667
Methodology: https://510kreport.com/methodology