Cleared Traditional

K152098 - ODALYS Pedicle Screw System

K152098 is an FDA 510(k) clearance for ODALYS Pedicle Screw System, manufactured by Kisco International. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K152098 · Kisco International · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
51d
Days
Class 2
Risk

K152098 is an FDA 510(k) clearance for the ODALYS Pedicle Screw System. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Kisco International (Saint-Priest, FR). The FDA issued a Cleared decision on September 17, 2015 after a review of 51 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 Kisco International devices

FDA 510(k) Submission Details - K152098

510(k) Number K152098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2015
Decision Date September 17, 2015
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 K152098.
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Reliance Spinal Screw System
K152131 · Reliance Medical Systems, LLC · Sep 2015
Sniper Spine System
K152174 · Spine Wave, Inc. · Aug 2015
Sniper Spine System
K151813 · Spine Wave, Inc. · Jul 2015