Cleared Traditional

VELOFIXTM INTERBODY FUSION SYSTEM (K132926) - FDA 510(k) Clearance

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

K132926 · U&I Corp. · Orthopedic device
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Mar 2014
Decision
168d
Days
Class 2
Risk

K132926 is an FDA 510(k) clearance for the VELOFIXTM INTERBODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by U&I Corp. (Uijeongbu-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 5, 2014 after a review of 168 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 U&I Corp. devices

Submission Details

510(k) Number K132926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date March 05, 2014
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 177
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K132926.
DIVERGENCE Anterior Cervical Fusion System
K142450 · Medtronic Sofamor Danek USA, Inc. · Oct 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · Exactech, Inc. · Aug 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · Medtronic Sofamor Danek USA, Inc. · Apr 2014
PERIMETER C SPINAL SYSTEM
K132584 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · Medtronic Sofamor Danek USA, Inc. · Sep 2013
PERIMETER C SPINAL SYSTEM
K100967 · Medtronic Sofamor Danek USA, Inc. · Aug 2011