Cleared Special

K031519 - CUFFLOK ANCHOR

K031519 is an FDA 510(k) clearance for CUFFLOK ANCHOR, manufactured by Mitek Worldwide. The device is a Class 2 Orthopedic device with product code MAI cleared through the Special 510(k) pathway after a 22-day FDA review.

K031519 · Mitek Worldwide · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
22d
Days
Class 2
Risk

K031519 is an FDA 510(k) clearance for the CUFFLOK ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Mitek Worldwide (Norwood, US). The FDA issued a Cleared decision on June 6, 2003 after a review of 22 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K031519

510(k) Number K031519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2003
Decision Date June 06, 2003
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 220
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K031519.
PANALOK LOOP ANCHOR
K040827 · Depuy Mitek, A Johnson & Johnson Company · Apr 2004
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · Smith & Nephew, Inc. · Aug 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981 · Linvatec Biomaterials, Ltd. · Jul 2003
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · Smith & Nephew, Inc. · Nov 2001
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465 · Bonutti Research, Inc. · Oct 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057 · Bionx Implants, Inc. · Oct 2001
K031519 · CUFFLOK ANCHOR
Download PDF FDA Summary Mitek Worldwide