| K-number | K253615 |
| Device name | Invictus Bands System |
| Applicant | Alphatec Spine, Inc. |
| Product code | OWI |
| Device class | Class II |
| Decision date | Mar 25, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3010 |
The Invictus® Bands System is a sublaminar fixation and ligament augmentation system consisting of bands, sleeves, connectors, and set screws designed to mate with 4.5–6.0 mm diameter spinal rods. It provides temporary stabilization and bone anchoring during spinal fusion and fracture repair, with applications in trauma surgery, spinal reconstructive procedures for deformity correction, degenerative spine surgery, and ligament augmentation.
The system features bands made of polyethylene terephthalate (PET) braid with stainless steel malleable tips and leads; sleeves, connectors, and set screws manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. Bands are single-use, terminally sterile via gamma irradiation; metal components are single-use, non-sterile, and steam-sterilizable by the end user. The system includes Class I reusable surgical instruments made of stainless steel and other materials.
ASTM F1798 Static Band Pull-Through and ASTM F1798 Dynamic Band Pull-Through testing were performed to support clearance.
View the full FDA submission: accessdata.fda.gov