# K241519: Invictus® Small Stature Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jun 21, 2024 after 23 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: 32 generations back to K841189 (1984). 1,095 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 1,098 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232275: Invictus® Spinal Fixation System, Alphatec Spine, Inc. (2023) Summary page 4.
- K223181: NuVasive Reline System, Nu Vasive, Incorporated (2023) Summary page 4.
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 4.
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012) Summary page 4.
- K181390: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System, OrthoPediatrics Corp. (2018) Summary page 4.
- K192938: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2019) Summary page 4.
- K152968: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2015) Summary page 6.

## Most influential descendants
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own
- K253615: Invictus Bands System (2026), 0 descendants of its own

## Indications for use
The Invictus® Small Stature Spinal Fixation System is intended for non-cervical posterior and anterolateral 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 Invictus® Small Stature 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® Small Stature 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® Small Stature Spinal Fixation System is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K241519
Methodology: https://510kreport.com/methodology