# K042930: Spacevision Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Dec 28, 2004 after 67 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: 6 generations back to K841189 (1984). 16 ancestors in all.
1,440 later devices descend from it; 2 cite it directly.
1 of 1,457 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 1.
- K042268: Ebi Cas Spine Spacer System, Ebi, L.P. (2004). Cleared while this submission was under review Summary page 1.
- K003709: Surgical Dynamics Mesh Cage System, United States Surgical, A Division of Tyco Healthc (2001) Summary page 1.

## Most influential descendants
- K062759: Paramount VBR System (2007), 1,406 descendants of its own
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own

## Indications for use
The Spacevision Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of 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 in the thoracolumbar spine (T1-5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.

Source page: https://510kreport.com/device/K042930
Methodology: https://510kreport.com/methodology