Cleared Special

K091763 - MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000

K091763 is an FDA 510(k) clearance for MICHELANGELO BUNION SYSTEM - MABS, manufactured by Instratek, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Special 510(k) pathway after a 59-day FDA review.

K091763 · Instratek, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
59d
Days
Class 2
Risk

K091763 is an FDA 510(k) clearance for the MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Instratek, Inc. (Spring, US). The FDA issued a Cleared decision on August 14, 2009 after a review of 59 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 - K091763

510(k) Number K091763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date August 14, 2009
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
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 - HTN Washer, Bolt Nut

All 91
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K091763.
CMC CABLE FIX
K111032 · Instratek, Inc. · Aug 2011
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K091207 · Surgicraft , Ltd. · Feb 2011
CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
K091799 · Zimmer, Inc. · Sep 2009
MINI TIGHTROPE
K090107 · Arthrex, Inc. · Aug 2009
HAV-LOK BUNION CORRECTION SYSTEM
K082384 · Instratek, Inc. · Dec 2008
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
K082095 · Smith & Nephew Endoscopy, Inc. · Oct 2008