# K232481: RIGEL™ 3DR Anterior Cervical Corpectomy System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Oct 13, 2023 after 58 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: 24 generations back to K841189 (1984). 257 ancestors in all.
No later device cites it as a predicate yet.
1 of 258 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193412: NEXXT MATRIXX System, Nexxt Spine, LLC (2020) Summary page 4.
- K152568: C-VBR, Cardinal Spine, LLC (2016) Summary page 4.

## Indications for use
The RIGEL™ 3DR Anterior Cervical Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2- T1) in skeletally mature patients. The RIGEL™ 3DR Anterior Cervical Corpectomy System 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 allogenic 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/K232481
Methodology: https://510kreport.com/methodology