Cleared Traditional

K112560 - APTUS(R) DISTAL HUMERUS SYSTEM

K112560 is an FDA 510(k) clearance for APTUS DISTAL HUMERUS SYSTEM, 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 104-day FDA review.

K112560 · Medartis AG · Orthopedic device
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Dec 2011
Decision
104d
Days
Class 2
Risk

K112560 is an FDA 510(k) clearance for the APTUS(R) DISTAL HUMERUS SYSTEM. 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 December 15, 2011 after a review of 104 days - within the typical 510(k) review window.

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 Medartis AG devices

FDA 510(k) Submission Details - K112560

510(k) Number K112560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2011
Decision Date December 15, 2011
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
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 1254
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K112560.
STRYKER RESORBABLE FIXATION SYSTEM
K113109 · Stryker · Dec 2011
AXSOS LOCKING PLATE SYSTEM
K112926 · Stryker Corp. · Dec 2011
RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
K112819 · Xiamen Double Engline Medical Material Co., Ltd. · Dec 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339 · Wrightmedicaltechnologyinc · Dec 2011
ASCENSION ATLAS HUMERAL PLATING SYSTEM
K110700 · Ascension Orthopedics, Inc. · Dec 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085 · Synthes USA Products, LLC · Nov 2011