Cleared Traditional

K180401 - TiWAVE-C Porous Titanium Cervical Cage

K180401 is the FDA 510(k) clearance for TiWAVE-C Porous Titanium Cervical Cage by Kalitec Direct, LLC. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K180401 · Kalitec Direct, LLC · Orthopedic device
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Jun 2018
Decision
120d
Days
Class 2
Risk

K180401 is an FDA 510(k) clearance for the TiWAVE-C™ Porous Titanium Cervical Cage. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Kalitec Direct, LLC (Orlando, US). The FDA issued a Cleared decision on June 14, 2018 after a review of 120 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 Kalitec Direct, LLC devices

Submission Details

510(k) Number K180401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2018
Decision Date June 14, 2018
Days to Decision 120 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
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Cherry Tree Consulting
Teresa Cherry

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 K180401.
HD LifeSciences Cervical IBFD System
K180364 · Hd Lifesciences, LLC · Jun 2018
MONET™ Anterior Cervical Interbody Fusion Cage System
K172788 · Ctl Medical Corporation · Jun 2018
EVOL® ha-C Cervical Interbody Fusion System
K180674 · Cutting Edge Spine, LLC · Jun 2018
Atlas Spine Expandable Cervical Interbody System
K180675 · Atlas Spine, Inc. · Jun 2018
PATRIOT COLONIAL Spacer, SUSTAIN Spacer
K173722 · Globus Medical, Inc. · May 2018
icotec Interbody Cage System
K172480 · Icotec AG · May 2018