# K232348: RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Oct 27, 2023 after 81 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 407 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 409 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200087: F3D Cervical Stand-Alone Interbody Fusion System, Corelink, LLC (2020) Summary page 4.

## Most influential descendants
- K260036: NeckTune™ 3D SA Cervical Cage (2026), 0 descendants of its own

## Indications for use
The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous disc levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. Devices are to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is intended for use with the bone screw fixation provided and requires no additional fixation.

Source page: https://510kreport.com/device/K232348
Methodology: https://510kreport.com/methodology