Cleared Traditional

K160904 - Expedium Spine System

K160904 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 91-day FDA review.

K160904 · Medos International SARL · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
91d
Days
Class 2
Risk

K160904 is an FDA 510(k) clearance for the Expedium Spine System, VIPER and VIPER 2 Systems. 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 (Le Locle, CH). The FDA issued a Cleared decision on July 1, 2016 after a review of 91 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 K160904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2016
Decision Date July 01, 2016
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 Consultant

Depuy Synthes Spine
Mitch Ohiwa

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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K160904.
PathLoc-L MIS Spinal System
K161766 · L & K Biomed Co., Ltd. · Aug 2016
Genesys Spine TiLock Cortical Spinal System
K161914 · Genesys Spine · Aug 2016
Threshold™ Pedicular Fixation System
K161694 · Spineology, Inc. · Jul 2016
Arsenal Spinal Fixation System
K161363 · Alphatec Spine, Inc. · Jun 2016
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016
Mariner Pedicle Screw System
K160902 · SeaSpine Orthopedics Corporation · May 2016