Cleared Traditional

K024115 - MICROFIX QUICKANCHOR PLUS

K024115 is an FDA 510(k) clearance for MICROFIX QUICKANCHOR PLUS, manufactured by Mitek Worldwide. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K024115 · Mitek Worldwide · Orthopedic device
Download Printable Device Report (PDF)
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Mar 2003
Decision
90d
Days
Class 2
Risk

K024115 is an FDA 510(k) clearance for the MICROFIX QUICKANCHOR PLUS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mitek Worldwide (Norwood, US). The FDA issued a Cleared decision on March 13, 2003 after a review of 90 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 Mitek Worldwide devices

FDA 510(k) Submission Details - K024115

510(k) Number K024115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2002
Decision Date March 13, 2003
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 851
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K024115.
STRYKER BIOZIP SUTURE ANCHOR
K023192 · Stryker Endoscopy · Mar 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · KARL STORZ Endoscopy-America, Inc. · Mar 2003
EBI DYNAFIX COMPRESSION BONE SCREW
K030706 · Ebi, L.P. · Mar 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · Stryker Endoscopy · Feb 2003
KOMPRESSOR SCREW SYSTEM
K024233 · Kinetikos Medical, Inc. · Feb 2003
PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM
K024086 · Biomet Orthopedics, Inc. · Jan 2003