Cleared Traditional

Stable-C Interbody System (K181621) - FDA 510(k) Clearance

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

K181621 · Nexus Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
121d
Days
Class 2
Risk

K181621 is an FDA 510(k) clearance for the Stable-C Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Nexus Spine, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 19, 2018 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nexus Spine, LLC devices

Submission Details

510(k) Number K181621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2018
Decision Date October 19, 2018
Days to Decision 121 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 93
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K181621.
Endoskeleton TCS Interbody Fusion Device
K191565 · Titan Spine, Inc. · Aug 2019
NEXXT MATRIXX Stand Alone Cervical System
K190546 · Nexxt Spine, LLC · May 2019
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
K190655 · SeaSpine Orthopedics Corporation · Apr 2019
MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
K182151 · Ctl Medical Corporation · Oct 2018
Genesys Spine AIS-C Cervical Stand-Alone System
K181295 · Genesys Spine · Aug 2018
Pro-Link® Ti Stand-Alone Cervical Spacer System
K180642 · Life Spine, Inc. · May 2018