# K151939: COALITION Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jan 29, 2016 after 199 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: 14 generations back to K003155 (2001). 64 ancestors in all.
152 later devices descend from it; 10 cite it directly.
0 of 217 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 5.
- K131449: Coalition Spacer, Globus Medical, Inc. (2013) Summary page 5.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 5.
- K150053: STALIF C; STALIF C-Ti, Centinel Spine, Inc. (2015) Summary page 5.

## Most influential descendants
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K161081: SeaSpine Shoreline ACS - Anterior Cervical Standalone System (2016), 83 descendants of its own
- K170569: SeaSpine Shoreline ACS - Anterior Cervical Standalone System (2017), 82 descendants of its own
- K190655: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System (2019), 74 descendants of its own
- K183083: Shoreline Cervical Interbody RT System (2019), 60 descendants of its own

## Indications for use
COALITION® Spacers (including COALITION AGX™ and COALITION MIS™) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. 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. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The COALITION® Spacer is a stand-alone interbody fusion device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The COALITION MIS™ Spacer is an interbody fusion device and is to be used with two titanium alloy screws or anchors which accompany the implants. When used with screws, COALITION MIS™ Spacers are stand-alone interbody fusion devices intended for use at one or two levels of the cervical spine (C2-T1). When used with anchors, COALITION MIS™ Spacers are intended for use at one level of the cervical spine (C2-T1) with additional supplemental fixation such as posterior cervical screw fixation. The COALITION AGX™ Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When used with the COALITION AGX™ Plate, the plate-spacer assembly takes on the indications for use of the COALITION AGX™ Spacer, with the COALITION AGX™ Plate acting as the supplemental fixation. The COALITION AGX™ Plate and Spacer assembly is a stand-alone device intended for use at one level of the cervical spine (C2-T1) and is to be used with two titanium alloy screws which accompany the implant. The COALITION AGX™ Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

Source page: https://510kreport.com/device/K151939
Methodology: https://510kreport.com/methodology