Cleared Special

K173535 - Endoskeleton TAS Interbody Fusion Device

K173535 is the FDA 510(k) clearance for Endoskeleton TAS Interbody Fusion Device by Titan Spine, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 90-day FDA review.

K173535 · Titan Spine, LLC · Orthopedic device
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Feb 2018
Decision
90d
Days
Class 2
Risk

K173535 is an FDA 510(k) clearance for the Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic In.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Titan Spine, LLC (Mequon, US). The FDA issued a Cleared decision on February 13, 2018 after a review of 90 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Titan Spine, LLC devices

Submission Details

510(k) Number K173535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2017
Decision Date February 13, 2018
Days to Decision 90 days
Submission Type Special
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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Mrc/X, 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K173535.
Valeo® C+CSC with Lumen Interbody Fusion Device
K173453 · Amedica Corp. · Mar 2018
ALTA Anterior Cervical Interbody Spacer
K173324 · Astura Medical · Feb 2018
Neurostructures Cavetto® Cervical Cage System
K172320 · Neurostructures, Inc. · Feb 2018
MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™
K172212 · Ctl Medical Corporation · Jan 2018
Cervical Spinal Truss System (CSTS) Interbody Fusion Device
K173159 · 4Web, Inc. · Jan 2018
SeaSpine Vu cPOD, Zuma-C, Complete Cervical
K172926 · SeaSpine Orthopedics Corporation · Dec 2017