Cleared Traditional

K101070 - EXPEDIUM SPINE SYSTEM

K101070 is the FDA 510(k) clearance for EXPEDIUM SPINE SYSTEM by Medos International SARL. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K101070 · Medos International SARL · Orthopedic device
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Aug 2010
Decision
137d
Days
Class 2
Risk

K101070 is an FDA 510(k) clearance for the EXPEDIUM SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medos International SARL (Raynham, US). The FDA issued a Cleared decision on August 31, 2010 after a review of 137 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 K101070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2010
Decision Date August 31, 2010
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K101070.
TSRH(R) SPINAL SYSTEM
K101772 · Medtronic Sofamor Danek · Sep 2010
CD HORIZON SPINAL SYSTEM
K091445 · Medtronic Sofamor Danek · Sep 2010
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
K100845 · Zimmer Spine, Inc. · Sep 2010
MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
K102235 · Stryker Spine · Aug 2010
QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
K093692 · Pioneer Surgical Technology · Aug 2010
MODIFICATION TO SYNTHES MATRIX SYSTEM
K100952 · Synthes Spine · Aug 2010