Cleared Traditional

K100359 - DARCO HEADED CANNULATED SCREW

K100359 is an FDA 510(k) clearance for DARCO HEADED CANNULATED SCREW, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K100359 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2010
Decision
132d
Days
Class 2
Risk

K100359 is an FDA 510(k) clearance for the DARCO HEADED CANNULATED SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 132 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 Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K100359

510(k) Number K100359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date June 24, 2010
Days to Decision 132 days
Submission Type Traditional
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
10d slower than avg
Panel avg: 122d · This submission: 132d
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 966
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K100359.
IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM
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K101696 · Zimmer, Inc. · Sep 2010
PRO-TOE VO HAMMERTOW IMPLANT SYSTEM
K101165 · Wrightmedicaltechnologyinc · Jul 2010
MODIFICATION TO HBS HEADLESS BONE SCREW
K101030 · Biopro, Inc. · Jun 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · Smith & Nephew, Inc. · May 2010
EXTREMITY MEDICAL SCREW SYSTEM
K093770 · Extremity Medical, LLC · Apr 2010