Cleared Traditional

Stable-C Interbody System (K231763) - FDA 510(k) Clearance

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

K231763 · Nexus Spine, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2023
Decision
66d
Days
Class 2
Risk

K231763 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 August 21, 2023 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nexus Spine, LLC devices

Submission Details

510(k) Number K231763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2023
Decision Date August 21, 2023
Days to Decision 66 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 122d · This submission: 66d
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 K231763.
Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System
K231704 · Life Spine, Inc. · Oct 2023
Cervical Spine Truss System (CSTS)
K231739 · 4Web Medical, Inc. · Sep 2023
ChoiceSpine Blackhawk Ti Cervical Spacer System
K223869 · Choice Spine, LLC · Sep 2023
SPICCA Stand-Alone Cervical Fusion Cages
K230608 · Southern Medical (Pty) , Ltd. · Aug 2023
Titus Titanium Cervical by SAGICO
K221138 · Sagico VA USA, LLC · Aug 2023
QUASAR Standalone ACIF System
K231808 · GS Medical Co., Ltd. · Jul 2023