Cleared Traditional

K133459 - ELITE IBF

K133459 is an FDA 510(k) clearance for ELITE IBF, manufactured by Innova Spinal Technologies, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K133459 · Innova Spinal Technologies, LLC · Orthopedic device
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Mar 2014
Decision
114d
Days
Class 2
Risk

K133459 is an FDA 510(k) clearance for the ELITE IBF. 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 Innova Spinal Technologies, LLC (Fr. Myers, US). The FDA issued a Cleared decision on March 6, 2014 after a review of 114 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 Innova Spinal Technologies, LLC devices

FDA 510(k) Submission Details - K133459

510(k) Number K133459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 12, 2013
Decision Date March 06, 2014
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
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 661
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K133459.
ALEUTIAN IBF SYSTEM
K133614 · K2m, Inc. · Apr 2014
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
K133455 · Pioneer Surgical Technology, Inc. · Mar 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · Medtronic Sofamor Danek USA, Inc. · Mar 2014
DEROYAL SPINE SPACER SYSTEM
K131292 · Deroyal Industries, Inc. · Feb 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · Spineart · Feb 2014
ARDIS INTERBODY SYSTEM
K133184 · Zimmer Spine, Inc. · Jan 2014