Cleared Traditional

K050657 - MONDEAL CONTOUR HO SYSTEM

K050657 is an FDA 510(k) clearance for MONDEAL CONTOUR HO SYSTEM, manufactured by Kapp Surgical Instrument, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K050657 · Kapp Surgical Instrument, Inc. · Orthopedic device
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Aug 2005
Decision
147d
Days
Class 2
Risk

K050657 is an FDA 510(k) clearance for the MONDEAL CONTOUR HO 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 Kapp Surgical Instrument, Inc. (Warrensville, US). The FDA issued a Cleared decision on August 8, 2005 after a review of 147 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 Kapp Surgical Instrument, Inc. devices

FDA 510(k) Submission Details - K050657

510(k) Number K050657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2005
Decision Date August 08, 2005
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

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 1016
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K050657.
SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
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MIOT PLATING SYSTEM
K051945 · Orthofix Srl · Sep 2005
CHARLOTTE COMPRESSION PLATE
K051908 · Wrightmedicaltechnologyinc · Aug 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · Wrightmedicaltechnologyinc · Aug 2005
OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES
K050681 · TriMed, Inc. · Jul 2005
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
K051410 · Acumed, LLC · Jul 2005