Cleared Traditional

MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM (K050457) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050457 · Merete Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
19d
Days
Class 2
Risk

K050457 is an FDA 510(k) clearance for the MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Merete Medical GmbH (New York, US). The FDA issued a Cleared decision on March 14, 2005 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Merete Medical GmbH devices

Submission Details

510(k) Number K050457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date March 14, 2005
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K050457.
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TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K043113 · DePuy Orthopaedics, Inc. · Jan 2005
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
K043039 · Synthes (Usa) · Jan 2005