Cleared Traditional

K100414 - PROTOE ENDOSORB SMALL HAMMER TOE PIN

K100414 is an FDA 510(k) clearance for PROTOE ENDOSORB SMALL HAMMER TOE PIN, manufactured by Merete Medical GmbH. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K100414 · Merete Medical GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
136d
Days
Class 2
Risk

K100414 is an FDA 510(k) clearance for the PROTOE ENDOSORB SMALL HAMMER TOE PIN. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Merete Medical GmbH (Berlin, DE). The FDA issued a Cleared decision on July 2, 2010 after a review of 136 days - within the typical 510(k) review window.

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: 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 GmbH devices

FDA 510(k) Submission Details - K100414

510(k) Number K100414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2010
Decision Date July 02, 2010
Days to Decision 136 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 59
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K100414.
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
K120871 · Smith & Nephew, Inc. · Jun 2012
ROCKWOOD CLAVICLE PINS
K103001 · DePuy Orthopaedics, Inc. · Feb 2011
TWISTCUT ENDOSORB SCREWS
K102777 · Merete Medical GmbH · Dec 2010
ACUMED CLAVICLE SCREW SYSTEM
K083144 · Acumed, LLC · Jun 2009
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498 · Musculoskeletal Transplant Foundation · Jul 2006
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · Synthes (Usa) · Apr 2004