Cleared Traditional

K191212 - CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191212 · Medos International SARL · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
141d
Days
Class 2
Risk

K191212 is an FDA 510(k) clearance for the CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM .... Classified as Growing Rod System (product code PGM), Class II - Special Controls.

Submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on September 24, 2019 after a review of 141 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 Medos International SARL devices

Submission Details

510(k) Number K191212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2019
Decision Date September 24, 2019
Days to Decision 141 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
19d slower than avg
Panel avg: 122d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.