# K200685: RIGEL 3DR Anterior Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Jun 11, 2020 after 87 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, 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: 21 generations back to K841189 (1984). 263 ancestors in all.
No later device cites it as a predicate yet.
1 of 264 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190618: RIGEL PEEK Anterior Cervical Interbody Fusion System, MiRus, LLC (2019) Summary page 4.
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.

## Indications for use
The RIGEL™ 3DR Anterior Cervical Interbody Fusion System is an anterior cervical interbody indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level or two contiguous 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 and supplemental fixation.

Source page: https://510kreport.com/device/K200685
Methodology: https://510kreport.com/methodology