Cleared Traditional

K092904 - PATHWAY IVB/VBR

K092904 is an FDA 510(k) clearance for PATHWAY IVB/VBR, manufactured by Custom Spine, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K092904 · Custom Spine, Inc. · Orthopedic device
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Dec 2009
Decision
92d
Days
Class 2
Risk

K092904 is an FDA 510(k) clearance for the PATHWAY IVB/VBR. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Custom Spine, Inc. (Parsippany, US). The FDA issued a Cleared decision on December 22, 2009 after a review of 92 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 - K092904

510(k) Number K092904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2009
Decision Date December 22, 2009
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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

All 252
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K092904.
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K091873 · Spineart · Sep 2009
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K082848 · Signus Medizintechnik GmbH · Jul 2009
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K091088 · Ldr Spine USA · Jul 2009