Cleared Traditional

K133287 - PRESSON SPINAL FIXATION SYSTEM

K133287 is an FDA 510(k) clearance for PRESSON SPINAL FIXATION SYSTEM, manufactured by Nexus Spine, LLC. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K133287 · Nexus Spine, LLC · Orthopedic device
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Feb 2014
Decision
123d
Days
Class 2
Risk

K133287 is an FDA 510(k) clearance for the PRESSON SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Nexus Spine, LLC (Salt Lake City, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Nexus Spine, LLC devices

FDA 510(k) Submission Details - K133287

510(k) Number K133287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date February 25, 2014
Days to Decision 123 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
1d slower than avg
Panel avg: 122d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 170
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K133287.
PedFuse Pedicle Screw System
K143377 · Spinefrontier, Inc. · Feb 2015
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · Spineart · May 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153 · Spinefrontier, Inc. · May 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403 · Spine Wave, Inc. · Jan 2014
PERFIX ILIAC SCREW SYSTEM
K132218 · U&I Corporation · Dec 2013
ANAX 5.5 SPINAL SYSTEM
K132101 · U&I Corporation · Nov 2013