# K233359: DOMINION Expandable Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Mar 8, 2024 after 161 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K841189 (1984). 106 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190426: ALTA Anterior Cervical Corpectomy System, Astura Medical, LLC (2019) Summary page 4.

## Most influential descendants
- K241468: Vertiwedge® Intraosseous System (2024), 1 descendant of its own
- K261810: Vertiwedge® Intraosseous System (2026), 0 descendants of its own

## Indications for use
The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the cervical spine (C2-T1), DOMINION spacers are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar spine (i.e. posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.

Source page: https://510kreport.com/device/K233359
Methodology: https://510kreport.com/methodology