Cleared Special

MERETEC CS, CORTICAL SCREWS (K130400) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130400 · Merete Medical GmbH · Orthopedic device
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Apr 2013
Decision
45d
Days
Class 2
Risk

K130400 is an FDA 510(k) clearance for the MERETEC CS, CORTICAL SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on April 5, 2013 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merete Medical GmbH devices

Submission Details

510(k) Number K130400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2013
Decision Date April 05, 2013
Days to Decision 45 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 401
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130400.
ARTHREX COMPRESSION FT SCREWS
K132217 · Arthrex, Inc. · Nov 2013
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · Wrightmedicaltechnologyinc · Apr 2012
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011