Cleared Special

K183557 - Endoskeleton TA Interbody Fusion Device

K183557 is the FDA 510(k) clearance for Endoskeleton TA Interbody Fusion Device by Titan Spine, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 53-day FDA review.

K183557 · Titan Spine, Inc. · Orthopedic device
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Feb 2019
Decision
53d
Days
Class 2
Risk

K183557 is an FDA 510(k) clearance for the Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion .... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Titan Spine, Inc. (Mequon, US). The FDA issued a Cleared decision on February 11, 2019 after a review of 53 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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, Inc. devices

Submission Details

510(k) Number K183557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2018
Decision Date February 11, 2019
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K183557.
ChoiceSpine Stealth Cervical Spacer System
K183397 · Choicespine, LP · Mar 2019
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K190322 · Spineart · Mar 2019
Shoreline Cervical Interbody RT System
K183083 · SeaSpine Orthopedics Corporation · Feb 2019
Velofix Interbody Fusion System
K190067 · U&I Corporation · Feb 2019
Cervical Spacer
K182477 · Additive Implants, LLC · Jan 2019
Tyber Medical PT Interbody Spacer
K182284 · Tyber Medical, LLC · Jan 2019