# K133802: Ais Modulift VBR System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap Implant System, Inc.
- Decided: Apr 17, 2014 after 125 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: 13 generations back to K003155 (2001). 48 ancestors in all.
48 later devices descend from it; 2 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110864: Biospine VBR System, Aesculap Implant Systems, LLC (2011) Summary page 1.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 2.
- K060416: Obelisc Vertebral Body Replacement Device, Ulrich GmbH & Co. KG (2006) Summary page 2.
- K050850: Xpand Corpectomy Spacer, Globus Medical, Inc. (2005) Summary page 2.
- K080568: X-Mesh Expandable Cage System, Depuy Spine, Inc. (2008) Summary page 2.

## Most influential descendants
- 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
- K191066: CD Horizon™ Astute™ Spinal System (2019), 21 descendants of its own

## Indications for use
The AIS Modulift VBR System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The AIS Modulift VBR System is intended for use with supplemental spinal fixation systems such as the Aesculap MACS TL or S4 Systems. The Aesculap Modulift VBR System may be used with bone graft.

Source page: https://510kreport.com/device/K133802
Methodology: https://510kreport.com/methodology