Cleared Special

K013503 - MODIFICATION TO: STERILE COLLES CLASSIC...

K013503 is an FDA 510(k) clearance for MODIFICATION TO: STERILE COLLES CLASSIC..., manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 25-day FDA review.

K013503 · DePuy Orthopaedics, Inc. · Orthopedic device
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Nov 2001
Decision
25d
Days
Class 2
Risk

K013503 is an FDA 510(k) clearance for the MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K013503

510(k) Number K013503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date November 16, 2001
Days to Decision 25 days
Submission Type Special
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K013503.
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K012024 · Ebi, L.P. · Jul 2001
MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM
K011711 · Ebi, L.P. · Jun 2001