Cleared Traditional

K162912 - VIPER PRIME™ additions to the VIPER® System

K162912 is an FDA 510(k) clearance for VIPER PRIME additions to the VIPER System, manufactured by Medos International SARL. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K162912 · Medos International SARL · Orthopedic device
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Dec 2016
Decision
52d
Days
Class 2
Risk

K162912 is an FDA 510(k) clearance for the VIPER PRIME™ additions to the VIPER® 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 (Lelocle, CH). The FDA issued a Cleared decision on December 8, 2016 after a review of 52 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.

View all Medos International SARL devices

FDA 510(k) Submission Details - K162912

510(k) Number K162912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2016
Decision Date December 08, 2016
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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
Laura Bleyendaal

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 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K162912.
JAZZ FRAME SYSTEM
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K162134 · Aesculap Implant Systems, LLC · Dec 2016
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K162160 · Amedica Corporation · Nov 2016
MOSS 100 Pedicle Screw System
K162232 · Biedermann Motech GmbH & Co. KG · Nov 2016
CD HORIZON® Spinal System
K162379 · Medtronic Sofamor Danek USA, Inc. · Nov 2016