Cleared Traditional

K160879 - CONFIDENCE High Viscosity Spinal Cement

K160879 is an FDA 510(k) clearance for CONFIDENCE High Viscosity Spinal Cement, manufactured by Medos International S?rl. The device is a Class 2 Orthopedic device with product code PML cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K160879 · Medos International S?rl · Orthopedic device
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Dec 2016
Decision
265d
Days
Class 2
Risk

K160879 is an FDA 510(k) clearance for the CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Sc.... Classified as Bone Cement, Posterior Screw Augmentation (product code PML), Class II - Special Controls.

Submitted by Medos International S?rl (Lelocle, CH). The FDA issued a Cleared decision on December 20, 2016 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 S?rl devices

FDA 510(k) Submission Details - K160879

510(k) Number K160879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2016
Decision Date December 20, 2016
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PML Device Classification - Class 2, Special Controls

Product Code PML Bone Cement, Posterior Screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
Definition The Device Is Intended To Augment The Fixation Of Screws In A Posterior Spinal System Construct.
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 - PML Bone Cement, Posterior Screw Augmentation

All 17
Devices cleared under the same product code (PML) and FDA review panel - the closest regulatory comparables to K160879.
NuVasive Reline Fenestrated Screws, High V+ Bone Cement
K180498 · Nu Vasive, Incorporated · Nov 2018
FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
K172269 · Globus Medical, Inc. · Mar 2018
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171938 · Medtronic · Oct 2017