Cleared Traditional

K133166 - INS HILDEN TIBIAL ARZZT

K133166 is an FDA 510(k) clearance for INS HILDEN TIBIAL ARZZT, manufactured by Truemed Group, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K133166 · Truemed Group, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
385d
Days
Class 2
Risk

K133166 is an FDA 510(k) clearance for the INS HILDEN TIBIAL ARZZT. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Truemed Group, LLC (Hampton, US). The FDA issued a Cleared decision on November 6, 2014 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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. Elevated predicate reliance profile. 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 Truemed Group, LLC devices

FDA 510(k) Submission Details - K133166

510(k) Number K133166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date November 06, 2014
Days to Decision 385 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
263d slower than avg
Panel avg: 122d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 367
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K133166.
OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System
K142451 · Merete Medical GmbH · Feb 2015
Acumed Small Bone IM Nail System
K143276 · Acumed, LLC · Feb 2015
ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
K141571 · Orthofix Srl · Nov 2014
ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM
K142281 · Zimmer, Inc. · Oct 2014
VALOR Hindfoot Fusion Nail System
K142602 · Wrightmedicaltechnologyinc · Oct 2014
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
K141228 · Advanced Orthopaedic Solutions, Inc. · Jul 2014