Cleared Traditional

K162194 - MEDICREA INTERNATIONAL Anterior Cervica...

K162194 is an FDA 510(k) clearance for MEDICREA INTERNATIONAL Anterior Cervica..., manufactured by Medicrea International SA. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K162194 · Medicrea International SA · Orthopedic device
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Dec 2016
Decision
125d
Days
Class 2
Risk

K162194 is an FDA 510(k) clearance for the MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medicrea International SA (Neyron, FR). The FDA issued a Cleared decision on December 8, 2016 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Medicrea International SA devices

FDA 510(k) Submission Details - K162194

510(k) Number K162194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2016
Decision Date December 08, 2016
Days to Decision 125 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
3d slower than avg
Panel avg: 122d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K162194.
Butrex Lumbar Buttress Plating System
K170530 · X-Spine Systems, Inc. · Mar 2017
LOSPA IS ACP System
K161641 · Corentec Co., Ltd. · Jan 2017
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016
AccuFit Lateral Plate System
K162211 · Precision Spine, Inc. · Nov 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016