Cleared Special

K192054 - Endoskeleton TAS Plate

K192054 is an FDA 510(k) clearance for Endoskeleton TAS Plate, manufactured by Titan Spine, Inc.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 29-day FDA review.

K192054 · Titan Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
29d
Days
Class 2
Risk

K192054 is an FDA 510(k) clearance for the Endoskeleton TAS Plate. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Titan Spine, Inc. (Mequon, US). The FDA issued a Cleared decision on August 29, 2019 after a review of 29 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.

FDA 510(k) Submission Details - K192054

510(k) Number K192054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2019
Decision Date August 29, 2019
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

OVD Device Classification - Class 2, Special Controls

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 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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 203
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K192054.
Stand-Alone ALIF Titanium System
K191834 · Life Spine, Inc. · Dec 2019
Idys ALIF ZP 3DTi
K192168 · Clariance, Sas · Nov 2019
SAHARA Stabilization System
K190179 · K2m, Inc. · Oct 2019
Rampart™ One Lumbar Interbody Fusion System
K192047 · Spineology, Inc. · Aug 2019
AXTi Titanium Stand-Alone ALIF System
K182139 · Innovasis, Inc. · Jun 2019
Idys ALIF TiVac
K191263 · Clariance, Sas · Jun 2019
K192054 · Endoskeleton TAS Plate
Download PDF FDA Summary Titan Spine, Inc.