# K143740: Battalion Universal Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 22, 2015 after 143 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 3 generations back to P980048 (2001). 8 ancestors in all.
247 later devices descend from it; 6 cite it directly.
0 of 256 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080699: Novel Spinal Spacer System, Alphatec Spine, Inc. (2008) Summary page 5.
- K110632: Lucent or Lucent Magnum, Spinal Elements, Inc. (2012) Summary page 5.

## Most influential descendants
- K153107: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System (2016), 171 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own
- K160958: Battalion Universal Spacer System (2016), 114 descendants of its own
- K180480: ATEC Universal Spacer System (2018), 113 descendants of its own

## Indications for use
The Battalion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as discogenic spinal pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have had at least six months of non-operative treatment. Lumbar DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Battalion System is to be used with autogenous bone graft and supplemental fixation.

Source page: https://510kreport.com/device/K143740
Methodology: https://510kreport.com/methodology