Cleared Traditional

K190618 - RIGEL PEEK Anterior Cervical Interbody Fusion System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190618 · MiRus, LLC · Orthopedic device
Jun 2019
Decision
87d
Days
Class 2
Risk

K190618 is an FDA 510(k) clearance for the RIGEL PEEK Anterior Cervical Interbody Fusion System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).

Submitted by MiRus, LLC (Marietta, US). The FDA issued a Cleared decision on June 6, 2019, 87 days after receiving the submission on March 11, 2019.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..

Submission Details

510(k) Number K190618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2019
Decision Date June 06, 2019
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 116d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 38
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K190618.
Flex-Z™ Cervical Cage
K252432 · Spinepoint, LLC · Mar 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105 · NanoHive Medical, LLC · Feb 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · Curiteva, Inc. · Jan 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · Curiteva, Inc. · Jan 2026
Cervical Interbody and VBR Fusion System
K252219 · Sync Surgical · Jan 2026
Advantage-C™ Ti3D Cervical Interbody Fusion Device
K252711 · Intelivation Technologies · Jan 2026