Cleared Traditional

PATHWAY AVID (K111726) - FDA 510(k) Clearance

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

K111726 · Custom Spine, Inc. · Orthopedic device
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Feb 2012
Decision
231d
Days
Class 2
Risk

K111726 is an FDA 510(k) clearance for the PATHWAY AVID. 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 Custom Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on February 6, 2012 after a review of 231 days - an extended review 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: 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 Custom Spine, Inc. devices

Submission Details

510(k) Number K111726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date February 06, 2012
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
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 427
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K111726.
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
K130434 · Exactech, Inc. · May 2013
CALIBER SPACERS
K123231 · Globus Medical, Inc. · Jan 2013
PATRIOT SPACERS
K122097 · Globus Medical, Inc. · Dec 2012
RISE SPACER
K113447 · Globus Medical, Inc. · Jan 2012
CALIBER SPACER
K102293 · Globus Medical, Inc. · Jan 2011
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · Globus Medical, Inc. · Dec 2010