# K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Jul 14, 2026 after 88 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: 34 generations back to K841189 (1984). 1,596 ancestors in all.
No later device cites it as a predicate yet.
7 of 1,597 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 6.
- K241519: Invictus® Small Stature Spinal Fixation System, Alphatec Spine, Inc. (2024) Summary page 6.
- K180337: EUROPA Pedicle Screw System, MiRus, LLC (2019) Summary page 6.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 7.
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation), Alphatec Spine, Inc. (2026) Summary page 7.

## Indications for use
The Invictus Small Stature Spinal Fixation System and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 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 and Invictus 2.0 Spinal Fixation System are 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 and Invictus 2.0 Spinal Fixation System are intended to be used with autograft and/or allograft. Invictus Small Stature/Invictus 2.0 SI.CORE Screws are intended to be used with Alphatec’s 4.5, 5.0, 5.5 and 6.0 mm diameter rods 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 Small Stature/Invictus 2.0 CORE and Invictus Small Stature/Invictus 2.0 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 Small Stature and Invictus 2.0 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 Small Stature and Invictus 2.0 Fenestrated Screws augmented with Invictus Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. Invictus 2.0 Navigation Instruments (for Use with StealthStation™) The Invictus 2.0 Navigation Instruments are intended to be used during the placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Navigation instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K261284
Methodology: https://510kreport.com/methodology