# K072465: Niko Corpectomy Spacer

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Oct 4, 2007 after 30 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). 5 ancestors in all.
327 later devices descend from it; 5 cite it directly.
0 of 333 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040284: Sustain Radiolucent Spacer, Globus Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K120570: Choice Spine Vertebral Body Replacement (VBR) Device System (2012), 322 descendants of its own
- K130573: Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif (2013), 251 descendants of its own
- K133967: Interbody Cage System (2014), 227 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

## Indications for use
The NIKOTM Corpectomy Spacer is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The NIKO TM Corpectomy Spacer is 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 spacer can be packed with bone grafting material. The NIKOTM Corpectomy Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Source page: https://510kreport.com/device/K072465
Methodology: https://510kreport.com/methodology