Cleared Special

K101278 - INERTIA PEDICLE SCREW SYSTEM

K101278 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 228-day FDA review.

K101278 · Nexxt Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
228d
Days
Class 2
Risk

K101278 is an FDA 510(k) clearance for the INERTIA PEDICLE SCREW SYSTEM. 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 December 20, 2010 after a review of 228 days - an extended review 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. Standard predicate reliance. 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 - K101278

510(k) Number K101278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2010
Decision Date December 20, 2010
Days to Decision 228 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 122d · This submission: 228d
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 171
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K101278.
VENUS BASIC SPINAL FIXATION SYSTEM
K103085 · L & K Biomed Co., Ltd. · Feb 2011
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · Ulrich GmbH & Co. KG · Jan 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · Exactech, Inc. · Jan 2011
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
K093771 · Pioneer Surgical Technology · Aug 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678 · Spineart · Jul 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706 · L & K Biomed Co., Ltd. · Jul 2010