Cleared Traditional

K170318 - NeoFuse Ti3D PLIF/TLIF/Cervical Interbody

K170318 is an FDA 510(k) clearance for NeoFuse Ti3D PLIF/TLIF/Cervical Interbody, manufactured by Ht Medical, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K170318 · Ht Medical, LLC · Orthopedic device
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Jul 2017
Decision
161d
Days
Class 2
Risk

K170318 is an FDA 510(k) clearance for the NeoFuse Ti3D PLIF/TLIF/Cervical Interbody. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Ht Medical, LLC (Tulsa, US). The FDA issued a Cleared decision on July 12, 2017 after a review of 161 days - an extended review cycle.

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 Ht Medical, LLC devices

FDA 510(k) Submission Details - K170318

510(k) Number K170318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2017
Decision Date July 12, 2017
Days to Decision 161 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
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 250
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K170318.
Matrixx System
K171140 · Nexxt Spine, LLC · Aug 2017
Calix-C Cervical Interbody Spacer
K171075 · X-Spine Systems, Inc. · Aug 2017
Velofix(tm) Interbody Fusion System
K171749 · U&I Corporation · Jul 2017
SeaSpine Cambria System
K171046 · SeaSpine Orthopedics Corporation · Jul 2017
Foundation 3D Interbody
K162496 · Corelink, LLC · May 2017
NuVasive CoRoent Small Interbody System
K163491 · Nu Vasive, Incorporated · Mar 2017