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K Number
K171372
Device Name
Alians Elbow Locking Plating System
Manufacturer
Newclip Technics
Date Cleared
2018-01-04

(239 days)

Product Code
HRS,HWC
Regulation Number
888.3030
Type
Special
Panel
Orthopedic
Reference & Predicate Devices
K152289,K102998,K912936,K103408
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults

Device Description

The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.

The implants of the Alians Elbow Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.

The instruments of the Alians Elbow Locking Plating System range will be provided non sterile for sterilization by health care professionals prior to use or sterile.

Materials: Titanium alloy Ti-6Al-4V (conform to ASTM F 136 and/or ISO 5832-3). The implants of the Alians Elbow Locking Function: Plating System are intended for the fixation of fractures and osteotomies of the distal humerus and the proximal ulna in adults.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System." As such, it does not contain any information regarding acceptance criteria or a study proving that an AI-driven device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

  • Intended Use: Fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
  • Design: Plates and screws.
  • Materials: Titanium alloy Ti-6Al-4V.
  • Mechanical Safety and Performance: Evaluated through engineering analysis (bending strength, bending stiffness, removable support).
  • Lack of Clinical Studies: Explicitly states "No clinical studies were performed."

Therefore, I cannot provide the requested information about acceptance criteria or an AI-driven device study from this document. The provided text is for a traditional medical implant device, not an AI or software-as-a-medical-device product.

§ 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.