# K133221: Arsenal Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Mar 13, 2014 after 146 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K040583 (2004). 104 ancestors in all.
150 later devices descend from it; 5 cite it directly.
0 of 255 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 2.
- K130646: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 2.

## Most influential descendants
- K143149: Arsenal Spinal Fixation System (2015), 84 descendants of its own
- K152968: Arsenal Spinal Fixation System (2015), 83 descendants of its own
- K142499: Reline System (2014), 78 descendants of its own
- K143684: NuVasive Reline System (2015), 77 descendants of its own
- K161363: Arsenal Spinal Fixation System (2016), 75 descendants of its own

## Recalls of this device
- May 5, 2017 · Class II · Z-2249-2017: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
- Oct 5, 2016 · Class II · Z-0592-2017: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

## 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 with autograft and/or allograft.

Source page: https://510kreport.com/device/K133221
Methodology: https://510kreport.com/methodology