Cleared Traditional

K964013 - MITEK ABSORBABLE TOGGLE ANCHOR

K964013 is an FDA 510(k) clearance for MITEK ABSORBABLE TOGGLE ANCHOR, manufactured by Mitek Products. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K964013 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
140d
Days
Class 2
Risk

K964013 is an FDA 510(k) clearance for the MITEK ABSORBABLE TOGGLE ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on February 24, 1997 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Products devices

FDA 510(k) Submission Details - K964013

510(k) Number K964013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1996
Decision Date February 24, 1997
Days to Decision 140 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 214
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K964013.
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
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BIOSPHERE SUTURE ANCHOR
K963396 · Instrument Makar, Inc. · May 1997
DEPUY DUPONT PHANTOM SUTURE ANCHOR
K964521 · Depuy, Inc. · Feb 1997
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K961789 · Zimmer, Inc. · Aug 1996
BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
K960555 · Instrument Makar, Inc. · Jul 1996