Cleared Traditional

K131522 - CORE PEDICLE SCREW SYSTEM

K131522 is an FDA 510(k) clearance for CORE PEDICLE SCREW SYSTEM, manufactured by Core-Nexus. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K131522 · Core-Nexus · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
73d
Days
Class 2
Risk

K131522 is an FDA 510(k) clearance for the CORE PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Core-Nexus (Austin, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Core-Nexus devices

FDA 510(k) Submission Details - K131522

510(k) Number K131522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date August 09, 2013
Days to Decision 73 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
49d faster than avg
Panel avg: 122d · This submission: 73d
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 199
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K131522.
INERTIA MIS PEDICLE SCREW SYSTEM
K132412 · Nexxt Spine, LLC · Oct 2013
EVEREST SPINAL SYSTEM
K132361 · K2m, Inc. · Oct 2013
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU
K132644 · Corentec Co., Ltd. · Sep 2013
CAPSURE PS SYSTEM
K132154 · Spine Wave, Inc. · Aug 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · Spinal USA · Jul 2013
REFORM PEDICLE SCREW SYSTEM
K130279 · Spinal USA · Jun 2013