# K072991: Patriot Spacers: Colonial Acdf

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 18, 2008 after 87 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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
No predicates in its family tree.
647 later devices descend from it; 11 cite it directly.
1 of 648 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K083389: Coalition Spacer (2009), 633 descendants of its own
- 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

## Indications for use
PATRIOTTM Spacers (ColonialTM ACDF) are interbody fusion devices intended 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. PATRIOTTMSpacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE@or PROVIDENCE@Anterior Cervical Plate System.

Source page: https://510kreport.com/device/K072991
Methodology: https://510kreport.com/methodology