Cleared Traditional

K032167 - BIO-INTRAFIX TIBIAL SCREW AND SHEATH

K032167 is an FDA 510(k) clearance for BIO-INTRAFIX TIBIAL SCREW AND SHEATH, 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 91-day FDA review.

K032167 · Mitek Worldwide · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
91d
Days
Class 2
Risk

K032167 is an FDA 510(k) clearance for the BIO-INTRAFIX TIBIAL SCREW AND SHEATH. 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 October 15, 2003 after a review of 91 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.

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FDA 510(k) Submission Details - K032167

510(k) Number K032167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2003
Decision Date October 15, 2003
Days to Decision 91 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
31d faster than avg
Panel avg: 122d · This submission: 91d
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 K032167.
LORENZ STERNAL CLOSURE SYSTEM
K033740 · Walter Lorenz Surgical, Inc. · Dec 2003
MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K033252 · Stryker Endoscopy · Nov 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · Biomet, Inc. · Nov 2003
ENDOTINE FOREHEAD DEVICE
K032770 · Coapt Systems, Inc. · Oct 2003
ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B
K032098 · Arthrex, Inc. · Oct 2003
LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE
K032072 · Arthrotek, Inc. · Oct 2003