# K112756: Fortify (TM) and Fortify (TM)-R Corpectomy Spacers

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Oct 7, 2011 after 16 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: 9 generations back to K003155 (2001). 30 ancestors in all.
268 later devices descend from it; 7 cite it directly.
0 of 299 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.
- K060665: Xpand Radiolucent Corpectomy Spacer, Globus Medical, Inc. (2006) Summary page 1.
- K060506: Stryker Spine Vlift Vertebral Body Replacement System, Stryker Spine (2006) Summary page 1.
- K003275: Synthes Synmesh Spacer System, Synthes (Usa) (2001) Summary page 1.
- K041389: Synthes Contoured Synmesh Spacer, Synthes Spine (2004) Summary page 1.

## Most influential descendants
- K121107: Fortify Integrated Corpectomy Spacers, (Fortify I and Fortify I-R) (2012), 214 descendants of its own
- K143578: SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer (2016), 210 descendants of its own
- K152022: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer (2017), 149 descendants of its own
- K161223: TransContinental® M Spacers and InterContinental® Plate-Spacers (2016), 117 descendants of its own
- K170157: INDEPENDENCE® Spacers (2017), 109 descendants of its own

## Indications for use
FORTIFYTM and FORTFYTM-R Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L-5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These devices are intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacers can be packed with autogenous bone graft or allograft. These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K112756
Methodology: https://510kreport.com/methodology