# K214006: Invictus® Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Apr 4, 2022 after 103 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: 29 generations back to K841189 (1984). 843 ancestors in all.
16 later devices descend from it; 2 cite it directly.
2 of 860 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213460: Invictus Spinal Fixation System, Alphatec Spine, Inc. (2021) Summary page 4.
- K203742: IdentiTi ALIF Standalone Interbody System, Alphatec Spine, Inc. (2021) Summary page 4.
- K183168: OpenLoc-L Spinal Fixation System, L&K BIOMED Co., Ltd. (2018) Summary page 4.
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 4.

## Most influential descendants
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K232275: Invictus® Spinal Fixation System (2023), 11 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K232044: Invictus Robotic Navigation Instruments (2023), 3 descendants of its own
- K241519: Invictus® Small Stature Spinal Fixation System (2024), 2 descendants of its own

## Indications for use
The Invictus 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 Invictus 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 Invictus 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 Invictus Spinal Fixation System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K214006
Methodology: https://510kreport.com/methodology