Cleared Traditional

Spine Innovation Interbody System (K153356) - FDA 510(k) Clearance

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

K153356 · Spine Innovation, LLC · Orthopedic device
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Jan 2016
Decision
55d
Days
Class 2
Risk

K153356 is an FDA 510(k) clearance for the Spine Innovation Interbody System. 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 Spine Innovation, LLC (Solana Beach, US). The FDA issued a Cleared decision on January 14, 2016 after a review of 55 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 Spine Innovation, LLC devices

Submission Details

510(k) Number K153356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date January 14, 2016
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 465
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153356.
NuVasive® TLX Interbody System
K153627 · Nu Vasive, Incorporated · Mar 2016
SUSTAIN Additional Implants
K151665 · Globus Medical, Inc. · Mar 2016
PERIMETER Interbody Fusion Device
K160418 · Medtronic Sofamor Danek USA, Inc. · Mar 2016
PIVOX(tm) Oblique Lateral Spinal System
K152277 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
NuVasive CoRoent Lumbar System
K151472 · Nu Vasive, Incorporated · Sep 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · Medtronic Sofamor Danek USA, Inc. · Aug 2015