# K110864: Biospine VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant Systems, LLC
- Decided: Jun 15, 2011 after 78 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: 12 generations back to K003155 (2001). 43 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012254: VBR, Osteotech, Inc. (2001) Summary page 2.
- K060416: Obelisc Vertebral Body Replacement Device, Ulrich GmbH & Co. KG (2006) Summary page 2.
- K010930: Lift VB Spinal System, Medtronic Sofamor Danek, Inc. (2001)
- K024049: Verte-Span Spinal System, Medtronic Sofamor Danek, Inc. (2003) Summary page 2.
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System, Aesculap Implant Systems, Inc. (2009) Summary page 2.

## Most influential descendants
- K133802: Ais Modulift VBR System (2014), 48 descendants of its own
- K142150: Ais Modulift VBR System (2014), 47 descendants of its own
- K172032: Modulift Vertebral Body Replacement (VBR) System (2017), 46 descendants of its own
- K181328: T2 STRATOSPHERE™ Expandable Corpectomy System (2018), 28 descendants of its own
- K183510: T2 STRATOSPHERE Expandable Corpectomy System (2019), 27 descendants of its own

## Indications for use
The Aesculap Biospine VBR System is indicated for use in the thoracolumbar spine (Ti to L_5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The Aesculap Biospine VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap VIBR System may be used with bone graft.

Source page: https://510kreport.com/device/K110864
Methodology: https://510kreport.com/methodology