Cleared Traditional

Stable-L Standalone Lumbar Interbody System (K231486) - FDA 510(k) Clearance

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

K231486 · Nexus Spine, LLC · Orthopedic device
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Oct 2023
Decision
142d
Days
Class 2
Risk

K231486 is an FDA 510(k) clearance for the Stable-L Standalone Lumbar Interbody System. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Nexus Spine, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 142 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 K231486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2023
Decision Date October 12, 2023
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar 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 Consultant

MRC Global
Christine Scifert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 115
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K231486.
Anterior Spine Truss System-Stand Alone (ASTS-SA)
K233966 · 4Web Medical, Inc. · Apr 2024
E3D™-A Interbody System
K232432 · Evolution Spine · Jan 2024
MectaLIF Anterior Lag Extension
K232123 · Medacta International S.A. · Oct 2023
IdentiTi ALIF Interbody Systems
K232097 · Alphatec Spine, Inc. · Sep 2023
Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
K232530 · Nexus Spine, LLC · Sep 2023
MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
K232154 · MiRus, LLC · Sep 2023