Cleared Traditional

K152011 - Lucent Intervertebral Body Fusion Device

K152011 is an FDA 510(k) clearance for Lucent Intervertebral Body Fusion Device, manufactured by Spinal Elements, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K152011 · Spinal Elements, Inc. · Orthopedic device
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Jun 2016
Decision
324d
Days
Class 2
Risk

K152011 is an FDA 510(k) clearance for the Lucent Intervertebral Body Fusion Device. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 9, 2016 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Spinal Elements, Inc. devices

FDA 510(k) Submission Details - K152011

510(k) Number K152011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2015
Decision Date June 09, 2016
Days to Decision 324 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
202d slower than avg
Panel avg: 122d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 853
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K152011.
Spinal Jaxx Interbody Fusion Device
K152501 · Neuropro Spinaljaxx, Inc. · Jun 2016
Nanovis Intervertebral Body Fusion System and FortiCore®
K160874 · Nanovis, LLC · Jun 2016
CoRoent® Ti-C System
K160916 · Nu Vasive, Incorporated · Jun 2016
LATERAL Spine Truss System
K153436 · 4Web, Inc. · Jun 2016
Reliance Lumbar IBF System
K160463 · Reliance Medical Systems, LLC · May 2016
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
K153107 · Choicespine, LP · May 2016