Cleared Special

K130400 - MERETEC CS

K130400 is an FDA 510(k) clearance for MERETEC CS, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 45-day FDA review.

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

FDA 510(k) Submission Details - K130400

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K130400.
MAXTORQUE SCREW SYSTEM
K131324 · Orthohelix Surgical Designs, Inc. · May 2013
AAP CANNULATED SCREW 2.0
K130590 · Aap Implantate AG · Apr 2013
EXTREMITY MEDICAL IP FUSION SYSTEM
K130120 · Extremity Medical, LLC · Apr 2013
ACUMED CANNULATED SCREW SYSTEM
K123890 · Acumed, LLC · Mar 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362 · Depuy Mitek, A Johnson & Johnson Company · Feb 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012