Cleared Traditional

K141509 - ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS

K141509 is an FDA 510(k) clearance for ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS, manufactured by Medos Sarl. The device is a Class 2 Orthopedic device with product code PGM cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K141509 · Medos Sarl · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
77d
Days
Class 2
Risk

K141509 is an FDA 510(k) clearance for the ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS. Classified as Growing Rod System (product code PGM), Class II - Special Controls.

Submitted by Medos Sarl (Raynham, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 77 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 - K141509

510(k) Number K141509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2014
Decision Date August 22, 2014
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PGM Device Classification - Class 2, Special Controls

Product Code PGM Growing Rod System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.
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 - PGM Growing Rod System

All 13
Devices cleared under the same product code (PGM) and FDA review panel - the closest regulatory comparables to K141509.
K2M Growing Spine System
K161028 · K2m, Inc. · Jul 2016
CD HORIZON Growth Rod Conversion Set
K150200 · Medtronic Sofamor Danek USA, Incorporated · Feb 2015
Xia® Growth Rod Conversion Set
K142114 · Stryker Corporation · Oct 2014
SHILLA GROWTH GUIDANCE SYSTEM
K140750 · Medtronic Sofamor Danek USA, Inc. · Jul 2014
CD HORIZON SPINAL SYSTEM GROWTH ROD SET
K133904 · Medtronic Sofamor Danek USA · Feb 2014
K141509 · ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
Download PDF FDA Summary Medos Sarl