# K143149: Arsenal Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Jan 5, 2015 after 63 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K040583 (2004). 105 ancestors in all.
84 later devices descend from it; 2 cite it directly.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100685: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2010) Summary page 4.
- K133221: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2014) Summary page 4.

## Most influential descendants
- K152968: Arsenal Spinal Fixation System (2015), 83 descendants of its own
- K161363: Arsenal Spinal Fixation System (2016), 75 descendants of its own
- K181677: Kodiak Spinal Fixation System (2018), 70 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own

## Indications for use
The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. Fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach. The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K143149
Methodology: https://510kreport.com/methodology