Cleared Traditional

K090063 - MERETE LOCKING BONE PLATE SYSTEM

K090063 is an FDA 510(k) clearance for MERETE LOCKING BONE PLATE SYSTEM, manufactured by Merete Medical, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K090063 · Merete Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
103d
Days
Class 2
Risk

K090063 is an FDA 510(k) clearance for the MERETE LOCKING BONE PLATE SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Merete Medical, Inc. (Rye, US). The FDA issued a Cleared decision on April 22, 2009 after a review of 103 days - within the typical 510(k) review window.

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: 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 Merete Medical, Inc. devices

FDA 510(k) Submission Details - K090063

510(k) Number K090063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2009
Decision Date April 22, 2009
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 318
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K090063.
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SMITH & NEPHEW RAIL SYSTEM
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ACE FISCHER EXTERNAL FIXATION SYSTEM
K083789 · DePuy Orthopaedics, Inc. · Mar 2009
REPROCESSED EXTERNAL FIXATION DEVICE
K083636 · Sterilmed, Inc. · Mar 2009
SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
K082650 · Synthes (Usa) · Nov 2008