Cleared Traditional

K130008 - DISTAL ULNA LOCKING PLATE (DUL)

K130008 is an FDA 510(k) clearance for DISTAL ULNA LOCKING PLATE (DUL), manufactured by I.T.S. GmbH. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K130008 · I.T.S. GmbH · Orthopedic device
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Jun 2013
Decision
174d
Days
Class 2
Risk

K130008 is an FDA 510(k) clearance for the DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANC.... Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by I.T.S. GmbH (Prior Lake, US). The FDA issued a Cleared decision on June 25, 2013 after a review of 174 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 - K130008

510(k) Number K130008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2013
Decision Date June 25, 2013
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1016
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