Cleared Traditional

K142940 - Endoskeleton TCS System

K142940 is an FDA 510(k) clearance for Endoskeleton TCS System, manufactured by Titan Spine, LLC. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K142940 · Titan Spine, LLC · Orthopedic device
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Jan 2015
Decision
111d
Days
Class 2
Risk

K142940 is an FDA 510(k) clearance for the Endoskeleton TCS System. 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 January 28, 2015 after a review of 111 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

FDA 510(k) Submission Details - K142940

510(k) Number K142940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2014
Decision Date January 28, 2015
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

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 Consultant

Memphis Regulatory Consulting, LLC
Christine Scifert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 162
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K142940.
STALIF C
K150053 · Centinel Spine, Inc. · Jun 2015
INCITE ANCHORED CERVICAL INTERBODY DEVICE
K150913 · Incite Innovation · Apr 2015
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
IN:C2 SPINAL FIXATION SYSTME
K141537 · Spine Smith Holdings, LLC · Nov 2014