# K253615: Invictus Bands System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Mar 25, 2026 after 127 days
- Product code: OWI (Bone Fixation Cerclage, Sublaminar)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 33 generations back to K841189 (1984). 1,110 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213659: LigaPASS™ 2.0 Ligament Augmentation System, Medicrea International SA (2022) Summary page 5.
- K232275: Invictus® Spinal Fixation System, Alphatec Spine, Inc. (2023) Summary page 5.
- K241519: Invictus® Small Stature Spinal Fixation System, Alphatec Spine, Inc. (2024) Summary page 5.

## Indications for use
The Invictus® Bands System consists of temporary implants for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: • Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; • Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; • Spinal degenerative surgery, as an adjunct to spinal fusions; • Use with a posterior spinal instrumentation construct when ligament augmentation is needed. The Invictus® Bands System may also be used in conjunction with other medical implants made of commercially pure titanium, titanium alloy, or cobalt chrome whenever "wiring" may help secure the attachment of other implants.

Source page: https://510kreport.com/device/K253615
Methodology: https://510kreport.com/methodology