Cleared Traditional

OLECRANONPLATE WITH ANGULAR STABILITY (K052368) - FDA 510(k) Clearance

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

K052368 · I.T.S. Implantat-Technologie-Systeme GmbH · Orthopedic device
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Oct 2005
Decision
49d
Days
Class 2
Risk

K052368 is an FDA 510(k) clearance for the OLECRANONPLATE WITH ANGULAR STABILITY. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by I.T.S. Implantat-Technologie-Systeme GmbH (Prior Lake, US). The FDA issued a Cleared decision on October 17, 2005 after a review of 49 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 I.T.S. Implantat-Technologie-Systeme GmbH devices

Submission Details

510(k) Number K052368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date October 17, 2005
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 K052368.
STRYKER PLATING SYSTEM
K060514 · Howmedica Osteonics Corp. · Mar 2006
ARTHREX TENSIONLOK
K052901 · Arthrex, Inc. · Dec 2005
SYNTHES (USA) STERNAL FIXATION SYSTEM
K052683 · Synthes (Usa) · Dec 2005
SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
K052677 · Synthes (Usa) · Oct 2005
SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
K052390 · Synthes (Usa) · Oct 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614 · Arthrex, Inc. · Sep 2005