# K083389: Coalition Spacer

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Mar 26, 2009 after 129 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: 1 generation back to K072991 (2008). 1 ancestor in all.
633 later devices descend from it; 22 cite it directly.
1 of 635 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072991: Patriot Spacers: Colonial Acdf, Globus Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K122630: IN:C2 Spinal Fixation System (2012), 405 descendants of its own
- K111439: Chesapeake (Cervical Components) (2011), 345 descendants of its own
- K133494: Chesapeake Spinal System (2014), 330 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K132999: Cervical Stand Alone System (2014), 281 descendants of its own

## Indications for use
The COALITION™ Spacer is a stand-alone interbody fusion device mtended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD 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 COALITION™ 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/K083389
Methodology: https://510kreport.com/methodology