Cleared Traditional

K132945 - CFN-CANNULATED FEMUR NAIL

K132945 is an FDA 510(k) clearance for CFN-CANNULATED FEMUR NAIL, manufactured by I.T.S. GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K132945 · I.T.S. GmbH · Orthopedic device
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Mar 2014
Decision
169d
Days
Class 2
Risk

K132945 is an FDA 510(k) clearance for the CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL .... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by I.T.S. GmbH (Prior Lake, US). The FDA issued a Cleared decision on March 7, 2014 after a review of 169 days - an extended review cycle.

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. 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 I.T.S. GmbH devices

FDA 510(k) Submission Details - K132945

510(k) Number K132945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2013
Decision Date March 07, 2014
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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
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