Cleared Traditional

K050655 - MONDEAL RADIUS HO SYSTEM

K050655 is an FDA 510(k) clearance for MONDEAL RADIUS 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.

K050655 · Kapp Surgical Instrument, Inc. · Orthopedic device
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Aug 2005
Decision
147d
Days
Class 2
Risk

K050655 is an FDA 510(k) clearance for the MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005. 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 - K050655

510(k) Number K050655 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 K050655.
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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