Cleared Special

K141376 - INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

K141376 is an FDA 510(k) clearance for INERTIA PEDICLE SCREW SYSTEM, manufactured by Nexxt Spine, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 30-day FDA review.

K141376 · Nexxt Spine, LLC · Orthopedic device
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Jun 2014
Decision
30d
Days
Class 2
Risk

K141376 is an FDA 510(k) clearance for the INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANT.... Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on June 26, 2014 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

View all Nexxt Spine, LLC devices

FDA 510(k) Submission Details - K141376

510(k) Number K141376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date June 26, 2014
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 294
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K141376.
GENERAL SPINAL SYSTEM
K134011 · Changzhou Dean Medical Instrument Co, Ltd. · Sep 2014
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
K133575 · Spinevision S.A. · Jun 2014
KANGLI PEDICLE SCREW SPINAL SYSTEM
K140053 · Suzhou Kangli Orthopaedics Instrument Co., Ltd. · Jun 2014
COSMOLOCK PEDICLE SCREW SYSTEM
K140678 · Kalitec Direct, LLC · Jun 2014
PLS (POSTERIOR LUMBAR SYSTEM)
K140787 · Sintea Plustek, LLC · May 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · Spineart · May 2014