Cleared Traditional

MERETE DUOTHREADTM BONE SCREW (K050924) - FDA 510(k) Clearance

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

K050924 · Merete Medical GmbH · Orthopedic device
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May 2005
Decision
44d
Days
Class 2
Risk

K050924 is an FDA 510(k) clearance for the MERETE DUOTHREADTM BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Merete Medical GmbH (New York, US). The FDA issued a Cleared decision on May 27, 2005 after a review of 44 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. 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 K050924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2005
Decision Date May 27, 2005
Days to Decision 44 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
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K050924.
ARTHREX TENODESIS FAMILY
K051726 · Arthrex, Inc. · Sep 2005
PLC SCREW
K051310 · Smith & Nephew, Inc. · Jul 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098 · Zimmer, Inc. · Jul 2005
ARTHREX TAK FAMILY
K050749 · Arthrex, Inc. · May 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · Synthes (Usa) · Apr 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · Synthes (Usa) · Apr 2005