Cleared Traditional

K892903 - MITEK ANCHOR DRILL

K892903 is an FDA 510(k) clearance for MITEK ANCHOR DRILL, manufactured by Mitek Surgical Products, Inc.. The device is a Class 1 Orthopedic device with product code HTW cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K892903 · Mitek Surgical Products, Inc. · Orthopedic device
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Oct 1989
Decision
169d
Days
Class 1
Risk

K892903 is an FDA 510(k) clearance for the MITEK ANCHOR DRILL. Classified as Bit, Drill (product code HTW), Class I - General Controls.

Submitted by Mitek Surgical Products, Inc. (Dedham, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 169 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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.

FDA 510(k) Submission Details - K892903

510(k) Number K892903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date October 06, 1989
Days to Decision 169 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

HTW Device Classification - Class 1, General Controls

Product Code HTW Bit, Drill
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HTW Bit, Drill

All 10
Devices cleared under the same product code (HTW) and FDA review panel - the closest regulatory comparables to K892903.
AGEE-WRISTJACK PRE-DRILL KIT
K942906 · Hand Biomechanics Lab, Inc. · Dec 1994
REAMER BIT
K930339 · Neoligaments, Ltd. · Aug 1993
CANNULATED DRILL BIT
K915692 · W.L. Gore & Associates, Inc. · Jan 1992
FEMORAL CEMENT REMOVAL INSTRUMENTS
K870217 · Kenneth J. Hoek, M.D., Inc. · Feb 1987
GLENOID DRILL
K863147 · Bowen & Company, Inc. · Sep 1986
DRILL BIT
K841629 · Plastafil, Inc. · Aug 1984
K892903 · MITEK ANCHOR DRILL
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