Cleared Traditional

MONDEAL HAND CONTOUR SYSTEM (K071797) - FDA 510(k) Clearance

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

K071797 · Mondeal Medical Systems GmbH · Orthopedic device
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Sep 2007
Decision
77d
Days
Class 2
Risk

K071797 is an FDA 510(k) clearance for the MONDEAL HAND CONTOUR SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Mondeal Medical Systems GmbH (San Diego, US). The FDA issued a Cleared decision on September 17, 2007 after a review of 77 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 Mondeal Medical Systems GmbH devices

Submission Details

510(k) Number K071797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date September 17, 2007
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 696
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K071797.
4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
K072423 · DePuy Orthopaedics, Inc. · Nov 2007
SMALL FRAGMENT LOCKING PLATING SYSTEM
K072083 · DePuy Orthopaedics, Inc. · Oct 2007
SMALL BONE WEDGE
K070592 · Wrightmedicaltechnologyinc · Oct 2007
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K071563 · Smith & Nephew, Inc. · Aug 2007
SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE
K071264 · Synthes (Usa) · Jul 2007
SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
K071184 · Synthes (Usa) · Jun 2007