# K111294: Santorini Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Jan 27, 2012 after 262 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: 8 generations back to K841189 (1984). 28 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060665: Xpand Radiolucent Corpectomy Spacer, Globus Medical, Inc. (2006) Summary page 1.
- K030736: Verte-Stack Spinal System, Extra Small Sizes, Medtronic Sofamor Danek (2003) Summary page 1.
- K841189: Oec/Rezaian Spinal Fixator, Orthopedic Equipment Co., Inc. (1984) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.
- K003155: Vertebral Body Replacement, Osteotech, Inc. (2001)
- K070381: Theken VU Mesh VBR System, Theken Spine, LLC (2007) Summary page 1.
- K040928: Expandable Peek VBR Implant, Interpore Cross Intl. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K085454: Aleutian Spacer System. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K142016: CAPRI (2014), 12 descendants of its own
- K170055: CAPRI Corpectomy Cage System (2017), 11 descendants of its own
- K171704: CAPRI Corpectomy Cage System (2017), 10 descendants of its own
- K180665: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System (2018), 9 descendants of its own
- K151481: Sahara Stabilization System (2015), 5 descendants of its own

## Indications for use
The Santorini Corpectomy Cage System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable vertebral bodies due to tumor or trauma (ie. fracture). The Santorini Spinal System is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The Santorini device may be used with allograft or autograft. For all the above indications the Santorini implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems

Source page: https://510kreport.com/device/K111294
Methodology: https://510kreport.com/methodology