Cleared Traditional

K163269 - Endoskeleton TAS Interbody Fusion Devic...

K163269 is the FDA 510(k) clearance for Endoskeleton TAS Interbody Fusion Devic... by Titan Spine, LLC. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K163269 · Titan Spine, LLC · Orthopedic device
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Apr 2017
Decision
143d
Days
Class 2
Risk

K163269 is an FDA 510(k) clearance for the Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordot.... Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Titan Spine, LLC (Mequon, US). The FDA issued a Cleared decision on April 13, 2017 after a review of 143 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 K163269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date April 13, 2017
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar 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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 148
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K163269.
Rampart One Lumbar Interbody Fusion Device
K163670 · Spineology, Inc. · May 2017
NuVasive BASE Interfixated Titanium System
K170592 · Nu Vasive, Incorporated · Apr 2017
Ax Stand-Alone ALIF System
K162236 · Innovasis, Inc. · Apr 2017
MectaLIF Anterior Stand Alone
K170455 · Medacta International S.A. · Mar 2017
SOVEREIGN® Spinal System
K162680 · Medtronic Sofamor Danek USA, Inc. · Dec 2016
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
K162351 · SeaSpine Orthopedics Corporation · Dec 2016