Cleared Special

K133950 - ACTIVAPIN HT

K133950 is an FDA 510(k) clearance for ACTIVAPIN HT, manufactured by Bioretec, Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 30-day FDA review.

K133950 · Bioretec, Ltd. · Orthopedic device
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Jan 2014
Decision
30d
Days
Class 2
Risk

K133950 is an FDA 510(k) clearance for the ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.). Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bioretec, Ltd. (Tampere, FI). The FDA issued a Cleared decision on January 22, 2014 after a review of 30 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 Bioretec, Ltd. devices

FDA 510(k) Submission Details - K133950

510(k) Number K133950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date January 22, 2014
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
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 - HTY Pin, Fixation, Smooth

All 111
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K133950.
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K130105 · Depuy Mitek, A Johnson & Johnson Company · May 2013
INTRAOSSEOUS FIXATION SYSTEM
K120165 · Orthohelix Surgical Designs, Inc. · Apr 2012