Cleared Traditional

K153615 - NeoFuse HA Enhanced PLIF/TLIF

K153615 is an FDA 510(k) clearance for NeoFuse HA Enhanced PLIF/TLIF, manufactured by Ht Medical, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K153615 · Ht Medical, LLC · Orthopedic device
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May 2016
Decision
141d
Days
Class 2
Risk

K153615 is an FDA 510(k) clearance for the NeoFuse HA Enhanced PLIF/TLIF. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Ht Medical, LLC (Tulsa, US). The FDA issued a Cleared decision on May 6, 2016 after a review of 141 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 Ht Medical, LLC devices

FDA 510(k) Submission Details - K153615

510(k) Number K153615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2015
Decision Date May 06, 2016
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 659
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153615.
Lucent Intervertebral Body Fusion Device
K152011 · Spinal Elements, Inc. · Jun 2016
Reliance Lumbar IBF System
K160463 · Reliance Medical Systems, LLC · May 2016
Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System
K153107 · Choicespine, LP · May 2016
Genesys Spine Apache Interbody Fusion System
K153123 · Genesys Spine · Apr 2016
Leva Spacer System
K153222 · Spine Wave, Inc. · Apr 2016
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer
K143578 · Globus Medical, Inc. · Apr 2016