Cleared Traditional

K061808 - DARCO LOCKING BONE PLATE SYSTEM

K061808 is an FDA 510(k) clearance for DARCO LOCKING BONE PLATE SYSTEM, manufactured by Darco International, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K061808 · Darco International, Inc. · Orthopedic device
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Aug 2006
Decision
51d
Days
Class 2
Risk

K061808 is an FDA 510(k) clearance for the DARCO LOCKING BONE PLATE 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 Darco International, Inc. (Huntington, US). The FDA issued a Cleared decision on August 17, 2006 after a review of 51 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 Darco International, Inc. devices

FDA 510(k) Submission Details - K061808

510(k) Number K061808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2006
Decision Date August 17, 2006
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 1086
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K061808.
SYNTHES LCP ANKLE ARTHRODESIS PLATES
K061940 · Synthes (Usa) · Sep 2006
KLS MARTIN STERNAL TALON
K051165 · KLS-Martin L.P. · Sep 2006
DISTAL RADIUS LOCKING PLATING SYSTEM
K061917 · Newclip Technics · Aug 2006
SYNTHES (USA) CLAVICLE HOOK PLATES
K061753 · Synthes (Usa) · Aug 2006
LISFRANC PLATE
K060474 · New Deal, S.A. · Aug 2006
MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM
K053624 · Medicon EG · Jul 2006