# K033109: Ellys and Aurys Vertebral Body Replacements

- Pathway: 510(k) (Traditional)
- Applicant: Scient'X
- Decided: Mar 23, 2004 after 175 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: 5 generations back to K841189 (1984). 11 ancestors in all.
1,218 later devices descend from it; 3 cite it directly.
1 of 1,230 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K021791: Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.

## Most influential descendants
- K043479: MC+ Partial VBR (2005), 1,214 descendants of its own
- K080728: LDR Spine Roi-C Implant (2008), 903 descendants of its own
- K083857: LDR Spine Roi-C Implant (2009), 902 descendants of its own
- K091088: LDR Spine Cervical Interbody Fusion System (2009), 901 descendants of its own
- K100042: Difusion Technologies Xiphos Interbody Fusion System (2010), 864 descendants of its own

## Indications for use
Ellys and Aurys Vertebral Body Replacements are vertebral body replacements for use in the lumbar and thoracic spine (T1-L5) to replace a damaged, collapsed or unstable vertebral body due to tumor or trauma (i.e. fracture). These are not stand-alone devices, ISOBAR 06.2 Hemispherical Screws with Offset Clamps and 05.5 Rods must be utilized to enhance the stability of the reconstruction in skeletally mature patients following full or partial corpectomy.

Source page: https://510kreport.com/device/K033109
Methodology: https://510kreport.com/methodology