# K232275: Invictus® Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Sep 27, 2023 after 58 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: 31 generations back to K841189 (1984). 1,035 ancestors in all.
11 later devices descend from it; 7 cite it directly.
2 of 1,047 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222774: iFuse Bedrock Granite® Implant System, SI-BONE, Inc. (2022) Summary page 5.
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System, Alphatec Spine, Inc. (2022) Summary page 5.
- K140738: Pass LP Spinal System, Medicrea International (2014) Summary page 6.

## Most influential descendants
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K241519: Invictus® Small Stature Spinal Fixation System (2024), 2 descendants of its own
- K240951: Invictus Robotic Navigation Instruments (2024), 2 descendants of its own
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (2026), 1 descendant of its own
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The Invictus 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 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. Invictus SI.CORE Screws are intended for sacroiliac joint fusion for the following conditions: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. Invictus CORE and Invictus SI.CORE Screws are not intended for use with cement; all other fenestrated screws may be used with Invictus Bone Cement. When used in conjunction with Invictus Bone Cement, the Invictus Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The Invictus Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

Source page: https://510kreport.com/device/K232275
Methodology: https://510kreport.com/methodology