Cleared Traditional

K141232 - APTUS ULNA SHORTENING 2.5

K141232 is an FDA 510(k) clearance for APTUS ULNA SHORTENING 2.5, manufactured by Medartis AG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K141232 · Medartis AG · Orthopedic device
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Jun 2014
Decision
41d
Days
Class 2
Risk

K141232 is an FDA 510(k) clearance for the APTUS ULNA SHORTENING 2.5. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Medartis AG (San Diego, US). The FDA issued a Cleared decision on June 23, 2014 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medartis AG devices

FDA 510(k) Submission Details - K141232

510(k) Number K141232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2014
Decision Date June 23, 2014
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
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 1255
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141232.
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ACUMED HAND FRACTURE SYSTEM
K141383 · Acumed, LLC · Jun 2014