Cleared Traditional

K133932 - INION FREEDOMPIN

K133932 is an FDA 510(k) clearance for INION FREEDOMPIN, manufactured by Inion OY. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K133932 · Inion OY · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
109d
Days
Class 2
Risk

K133932 is an FDA 510(k) clearance for the INION FREEDOMPIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on April 11, 2014 after a review of 109 days - within the typical 510(k) review window.

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 Inion OY devices

FDA 510(k) Submission Details - K133932

510(k) Number K133932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date April 11, 2014
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 108
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K133932.
PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM
K141714 · Wrightmedicaltechnologyinc · Oct 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004 · Orthohelix Surgical Designs, Inc. · Aug 2014
ARTHREX PIP DART
K141577 · Arthrex, Inc. · Jul 2014
WMT IMPLANTABLE K-WIRE
K132895 · Wrightmedicaltechnologyinc · Oct 2013
RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
K130105 · Depuy Mitek, A Johnson & Johnson Company · May 2013
INTRAOSSEOUS FIXATION SYSTEM
K120165 · Orthohelix Surgical Designs, Inc. · Apr 2012