# K190618: RIGEL PEEK Anterior Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Jun 6, 2019 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: 20 generations back to K841189 (1984). 238 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160324: Cervical Interbody Fusion System, Evolution Spine, LLC (2016) Summary page 4.
- K182920: MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO™ PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES™ PEEK Anterior Lumbar Interbody Fusion (ALIF), MiRus, LLC (2019). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K200685: RIGEL 3DR Anterior Cervical Interbody Fusion System (2020), 0 descendants of its own

## Indications for use
The RIGEL™ PEEK 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/K190618
Methodology: https://510kreport.com/methodology