Cleared Special

K983818 - MITEK FASTIN RC ANCHOR

K983818 is an FDA 510(k) clearance for MITEK FASTIN RC ANCHOR, manufactured by Mitek Products. The device is a Class 2 Orthopedic device with product code MBI cleared through the Special 510(k) pathway after a 25-day FDA review.

K983818 · Mitek Products · Orthopedic device
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Nov 1998
Decision
25d
Days
Class 2
Risk

K983818 is an FDA 510(k) clearance for the MITEK FASTIN RC ANCHOR. Classified as Fastener, Fixation, Nondegradable, Soft Tissue within the MBI classification (a category for soft tissue fixation fasteners and anchoring systems), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on November 23, 1998 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mitek Products devices

FDA 510(k) Submission Details - K983818

510(k) Number K983818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1998
Decision Date November 23, 1998
Days to Decision 25 days
Submission Type Special
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

MBI Device Classification - Class 2, Special Controls

Product Code MBI Fastener, Fixation, Nondegradable, Soft Tissue
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 - MBI Fastener, Fixation, Nondegradable, Soft Tissue

All 564
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K983818.
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM
K984200 · R. Thomas Grotz, M.D., Inc. · Jan 1999
STRYKER WEDGE SUTURE ANCHOR
K983557 · Stryker Endoscopy · Dec 1998
POLYMER THREADED ANCHOR
K983169 · Orthopaedic Biosystems, Ltd. · Dec 1998
INNOVASIVE TIBIAL FASTENER
K983056 · Innovasive Devices, Inc. · Oct 1998
KSEA FLIPPTACK
K982571 · KARL STORZ Endoscopy-America, Inc. · Sep 1998
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
K982169 · Doctor'S Research Group, Inc. · Sep 1998