Cleared Traditional

K133103 - AVERSION PEDICLE SCREW SYSTEM

K133103 is an FDA 510(k) clearance for AVERSION PEDICLE SCREW SYSTEM, manufactured by K7, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K133103 · K7, LLC · Orthopedic device
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Jan 2014
Decision
119d
Days
Class 2
Risk

K133103 is an FDA 510(k) clearance for the AVERSION PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by K7, LLC (Chesterland, US). The FDA issued a Cleared decision on January 27, 2014 after a review of 119 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 K7, LLC devices

FDA 510(k) Submission Details - K133103

510(k) Number K133103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date January 27, 2014
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle 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 - MNI Orthosis, Spinal Pedicle Fixation

All 194
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K133103.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS
K141835 · Spineart · Sep 2014
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
K141397 · Precision Spine, Inc. · Jun 2014
MYSPINE PEDICLE SCREW PLACEMENT GUIDES
K132788 · Medacta International · May 2014
EVEREST SPINAL SYSTEM
K132757 · K2m, Inc. · Nov 2013
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · Nexxt Spine, LLC · Oct 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013