# K060416: Obelisc Vertebral Body Replacement Device

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich GmbH & Co. KG
- Decided: Dec 26, 2006 after 312 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 K003275 (2001). 7 ancestors in all.
56 later devices descend from it; 9 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050850: Xpand Corpectomy Spacer, Globus Medical, Inc. (2005) Summary page 1.
- K012254: VBR, Osteotech, Inc. (2001) Summary page 1.

## Most influential descendants
- K110864: Biospine VBR System (2011), 49 descendants of its own
- 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

## Indications for use
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obeliscTM Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bone grafting material with the obeliscTM Vertebral Body Replacement is optional.

Source page: https://510kreport.com/device/K060416
Methodology: https://510kreport.com/methodology