# K173982: FORTIFY Corpectomy Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Sep 19, 2018 after 264 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: 14 generations back to K841189 (1984). 62 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162315: FORTIFY Corpectomy Spacers, Globus Medical, Inc. (2017) Summary page 4.
- K112756: Fortify (TM) and Fortify (TM)-R Corpectomy Spacers, Globus Medical, Inc. (2011) Summary page 4.
- K050850: Xpand Corpectomy Spacer, Globus Medical, Inc. (2005) Summary page 4.

## Most influential descendants
- K192117: Small VBR™ (2019), 6 descendants of its own
- K211892: ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (2022), 2 descendants of its own
- K252686: EffortMed PEEK Cages & Corpectomy Cages (2025), 1 descendant of its own
- K200235: KONG-TL VBR System, KONG-C VBR System (2020), 1 descendant of its own
- K260850: Osteomni Spinal Cages System (2026), 0 descendants of its own

## Indications for use
FORTIFY® and FORTIFY® Integrated Corpectomy Spacers are vertebral body replacement devices intended for use in the thoracolumbar spine (T1-L5). FORTIFY® Spacers (titanium) are also intended for use in the cervical spine (C2-T1). All FORTIFY® TPS coated spacers are indicated for the same use as non-coated PEEK versions. When used in the cervical spine (C2-T1), FORTIFY® devices (titanium) are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. These spacers are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion. When used in the thoracolumbar spine (T1-L5), FORTIFY® and FORTIFY® Integrated devices are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion. These devices are intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the cervical, thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Source page: https://510kreport.com/device/K173982
Methodology: https://510kreport.com/methodology