Cleared Traditional

K953560 - MITEK THREADED ANCHOR (FASTIN)

K953560 is the FDA 510(k) clearance for MITEK THREADED ANCHOR (FASTIN) by Mitek Surgical Products, Inc.. It is a Class 2 Orthopedic device (product code MBI) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K953560 · Mitek Surgical Products, Inc. · Orthopedic device
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Jan 1996
Decision
195d
Days
Class 2
Risk

K953560 is an FDA 510(k) clearance for the MITEK THREADED ANCHOR (FASTIN). 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 Surgical Products, Inc. (Westwood, US). The FDA issued a Cleared decision on January 31, 1996 after a review of 195 days - an extended review cycle.

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 Surgical Products, Inc. devices

Submission Details

510(k) Number K953560 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 20, 1995
Decision Date January 31, 1996
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 391
Devices cleared under the same product code (MBI) and FDA review panel - the closest regulatory comparables to K953560.
QUESTLOCK ACL FIXATOR
K954683 · Wrightmedicaltechnologyinc · Apr 1996
FASTAK SUTURE ANCHOR
K960516 · Arthrex, Inc. · Apr 1996
PRELOADED SOFT TISSUE ANCHOR
K953954 · Linvatec Corp. · Feb 1996
WASHER
K953702 · Linvatec Corp. · Oct 1995
QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM
K953264 · Wrightmedicaltechnologyinc · Oct 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · Arthrex, Inc. · Sep 1995