Cleared Traditional

K130177 - ANATOMIC PEEK CERVICAL FUSION SYSTEM

K130177 is the FDA 510(k) clearance for ANATOMIC PEEK CERVICAL FUSION SYSTEM by Medtronic Sofamor Danek USA, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K130177 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
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Sep 2013
Decision
241d
Days
Class 2
Risk

K130177 is an FDA 510(k) clearance for the ANATOMIC PEEK CERVICAL FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on September 23, 2013 after a review of 241 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 Medtronic Sofamor Danek USA, Inc. devices

Submission Details

510(k) Number K130177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2013
Decision Date September 23, 2013
Days to Decision 241 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 122d · This submission: 241d
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 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K130177.
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · Genesys Spine · Dec 2013
PERIMETER C SPINAL SYSTEM
K132584 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
TYBER MEDICAL INTERBODY SYSTEM
K130573 · Tyber Medical, LLC · Sep 2013
VUSION CS PLUS
K122588 · Ortho Development Corp. · Jun 2013
TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
K122366 · Spineart · Oct 2012
AVS AS PEEK SPACER
K120486 · Stryker Spine · Aug 2012