# K131449: Coalition Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 30, 2013 after 71 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K003155 (2001). 41 ancestors in all.
235 later devices descend from it; 6 cite it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083389: Coalition Spacer, Globus Medical, Inc. (2009) Summary page 1.
- K112459: Synthes Zero-P, Synthes Spine Co.Lp (2011) Summary page 1.

## Most influential descendants
- 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
- K151939: COALITION Spacers (2016), 152 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
The COALITION® Spacer is a stand-alone interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DOD) of the cervical spine (C2-T1) at one level. ODD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The COALITIONO Spacer is to be filled with autogenous bone graft material, and is to be used with two titanium alloy screws which accompany the implant.

Source page: https://510kreport.com/device/K131449
Methodology: https://510kreport.com/methodology