Cleared Traditional

K062103 - DARCO FORCE TITANIUM COMPRESSION SCREW

K062103 is an FDA 510(k) clearance for DARCO FORCE TITANIUM COMPRESSION SCREW, manufactured by Darco International, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K062103 · Darco International, Inc. · Orthopedic device
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Oct 2006
Decision
93d
Days
Class 2
Risk

K062103 is an FDA 510(k) clearance for the DARCO FORCE TITANIUM COMPRESSION SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Darco International, Inc. (Huntington, US). The FDA issued a Cleared decision on October 25, 2006 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Darco International, Inc. devices

FDA 510(k) Submission Details - K062103

510(k) Number K062103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date October 25, 2006
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 805
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K062103.
ARTHREX PUSHLOCK
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K062352 · DePuy Orthopaedics, Inc. · Oct 2006
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K062617 · Inion , Ltd. · Oct 2006