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K Number
K112169
Device Name
APTUS WRIST ARTHRODESIS PLATES
Manufacturer
MEDARTIS AG
Date Cleared
2012-01-06

(162 days)

Product Code
HRS
Regulation Number
888.3030
Type
Traditional
Panel
OR
Reference & Predicate Devices
K990094,K023879,K042355,K011458,K000558,K051567
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

Device Description

The APTUS® Wrist Arthrodesis Plates system is intended to be used for internal fixation of wrist fusions and consists of three titanium locking plates. The plates are secured using previously cleared titanium screws. APTUS Wrist Arthrodesis Plates are provided in various sizes.

AI/ML Overview

This document, a 510(k) Summary for the Medartis AG APTUS® Wrist Arthrodesis Plates (K112169), describes a medical device, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details, and AI/ML specific aspects like training sets, ground truth methodology for AI, and MRMC studies are not applicable and not present in the provided text.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, a requirement for 510(k) submissions.

Therefore, I cannot populate the requested table and details as they relate to AI/ML device performance and testing, which are not covered in this type of submission.

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.