Cleared Traditional

K151596 - Endoskeleton TCS Interbody Fusion Device

K151596 is the FDA 510(k) clearance for Endoskeleton TCS Interbody Fusion Device by Titan Spine, LLC. It is a Class 2 Orthopedic device (product code OVE) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K151596 · Titan Spine, LLC · Orthopedic device
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Oct 2015
Decision
119d
Days
Class 2
Risk

K151596 is an FDA 510(k) clearance for the Endoskeleton TCS Interbody Fusion Device. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Titan Spine, LLC (Mequon, US). The FDA issued a Cleared decision on October 9, 2015 after a review of 119 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 Titan Spine, LLC devices

Submission Details

510(k) Number K151596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2015
Decision Date October 09, 2015
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, 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 With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 115
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K151596.
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
K153352 · Spinal Elements, Inc. · Aug 2016
Cervical Stand Alone System
K161280 · Orthofix, Inc. · Jun 2016
COALITION Spacers
K151939 · Globus Medical, Inc. · Jan 2016
SCARLET® AC-T Secured Anterior Cervical Cage
K143214 · Spineart · Feb 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · Medtronic Sofamor Danek USA, Inc. · Jan 2015
Crystal ®
K133218 · Spinal Elements, Inc. · Dec 2014