Cleared Traditional

K120493 - MINI CANNULATED HEADED AND HEADLESS SCREW SET

K120493 is an FDA 510(k) clearance for MINI CANNULATED HEADED AND HEADLESS SCR..., manufactured by Instratek, Inc.. 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.

K120493 · Instratek, Inc. · Orthopedic device
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May 2012
Decision
90d
Days
Class 2
Risk

K120493 is an FDA 510(k) clearance for the MINI CANNULATED HEADED AND HEADLESS SCREW SET. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Instratek, Inc. (Houston, US). The FDA issued a Cleared decision on May 17, 2012 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 Instratek, Inc. devices

FDA 510(k) Submission Details - K120493

510(k) Number K120493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2012
Decision Date May 17, 2012
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 742
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K120493.
PMT BONE SCREWS
K121713 · Providence Medical Technology, Inc. · Sep 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · Extremity Medical, LLC · Jul 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417 · Extremity Medical, LLC · Jul 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · Wrightmedicaltechnologyinc · Apr 2012
COLS PEEK
K113591 · Fournitures Hospitalieres Industrie · Dec 2011
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011