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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Rich Jansen, Pharm.D.
Rich Jansen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K152098.
WASTON General Spinal System
K150684 · Changzhou Waston Medical Appliance Co., Ltd. · Nov 2015
X-spine Pedicle Screw System
K152132 · X-Spine Systems, Inc. · Sep 2015
Gemmed pedicle screw spinal system
K151592 · Suzhou Gemmed Medical Instrument Co., Ltd. · 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
K152098 · ODALYS Pedicle Screw System
Download PDF FDA Summary Kisco International