# K161363: Arsenal Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Alphatec Spine, Inc.
- Decided: Jun 10, 2016 after 24 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: 16 generations back to K040583 (2004). 161 ancestors in all.
75 later devices descend from it; 9 cite it directly.
0 of 237 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133221: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2014) Summary page 4.
- K143149: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2015) Summary page 4.
- K152968: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2015) Summary page 4.
- K100685: Zodiac Polyaxial Spinal Fixation System, Alphatec Spine, Inc. (2010) Summary page 4.
- K142591: CD HORIZON Spinal System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 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 pedicle screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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/K161363
Methodology: https://510kreport.com/methodology