Cleared Traditional

K153786 - PROW FUSION-V

K153786 is an FDA 510(k) clearance for PROW FUSION-V, manufactured by Nlt Spine, Ltd.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K153786 · Nlt Spine, Ltd. · Orthopedic device
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Jul 2016
Decision
193d
Days
Class 2
Risk

K153786 is an FDA 510(k) clearance for the PROW FUSION-V. 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 Nlt Spine, Ltd. (Kfar-Saba, IL). The FDA issued a Cleared decision on July 11, 2016 after a review of 193 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 Nlt Spine, Ltd. devices

FDA 510(k) Submission Details - K153786

510(k) Number K153786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2015
Decision Date July 11, 2016
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
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 661
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K153786.
Juliet® Ti
K153621 · Spineart · Jul 2016
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AccuLIF TL and PL Cage
K160715 · Stryker Corporation · Jul 2016
CoRoent® Ti-C System
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Lucent Intervertebral Body Fusion Device
K152011 · Spinal Elements, Inc. · Jun 2016