# K050997: Expanse Vertebral Body Replacement Device

- Pathway: 510(k) (Traditional)
- Applicant: Flexuspine, Inc.
- Decided: Oct 7, 2005 after 170 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022793: Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 1.
- K033663: Spinal Concepts Inc. Coda, Spinal Concepts, Inc. (2004) Summary page 1.

## Indications for use
The EXPANSE Vertebral Body Replacement (VBR) Device is indicated for use in the thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body which has been resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The EXPANSE VBR Device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The EXPANSE VBR Device is intended to be used with bone graft and supplemental fixation. The supplemental internal fixation systems that may be used with the EXPANSE VBR Device include the Zodiac Polyaxial Pedicle Screw System, the Expedium Spinal System, the Expedium Anterior system, and the CD Horizon Spinal System, or equivalent systems. The EXPANSE VBR Device may be implanted singularly or in pairs.

Source page: https://510kreport.com/device/K050997
Methodology: https://510kreport.com/methodology