Cleared Traditional

K090566 - PATHWAY AVID

K090566 is an FDA 510(k) clearance for PATHWAY AVID, manufactured by Custom Spine, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K090566 · Custom Spine, Inc. · Orthopedic device
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Jun 2009
Decision
90d
Days
Class 2
Risk

K090566 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 June 1, 2009 after a review of 90 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 Custom Spine, Inc. devices

FDA 510(k) Submission Details - K090566

510(k) Number K090566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2009
Decision Date June 01, 2009
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 K090566.
DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
K091638 · Spinefrontier, Inc. · Sep 2009
IBEX SPINAL SYSTEM
K091381 · Ebi, L.P. · Aug 2009
MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM
K090507 · Ldr Spine USA · Jun 2009
DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS
K081917 · Depuy Spine, Inc. · May 2009
GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM
K090425 · Alphatec Spine, Inc. · May 2009
DEPUY SPINE LATERAL SYSTEM
K090899 · Depuy Spine, Inc. · May 2009