# K190426: ALTA Anterior Cervical Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical, LLC
- Decided: Oct 24, 2019 after 244 days
- Product code: PLR (Spinal Vertebral Body Replacement Device - Cervical)
- 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: 16 generations back to K841189 (1984). 105 ancestors in all.
3 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)
- K180550: NuVasive Monolith Cervical Corpectomy System, Nu Vasive, Incorporated (2018) Summary page 4.
- K160154: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2016) Summary page 4.
- K173324: ALTA Anterior Cervical Interbody Spacer, Astura Medical (2018) Summary page 4.

## Most influential descendants
- K233359: DOMINION Expandable Corpectomy System (2024), 2 descendants of its own
- K241468: Vertiwedge® Intraosseous System (2024), 1 descendant of its own
- K261810: Vertiwedge® Intraosseous System (2026), 0 descendants of its own

## Indications for use
The ALTA Anterior Cervical Corpectomy Spacer is indicated for vertebral body replacement in the cervical spine (C3-C7) in skeletally mature patients. The Alta Anterior Cervical Corpectomy Spacer is intended to replace a diseased or damaged vertebral body caused by fracture, osteomyelitis, or tumor, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine. 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. The System is also 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 expectance is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.

Source page: https://510kreport.com/device/K190426
Methodology: https://510kreport.com/methodology