Metal femoral neck fixation nail with osseointegration implant

This document specifies the terminology and definitions, requirements, test methods, manufacturing, sterilization, packaging, and information provided by the manufacturer of metal femoral neck fixation nails (hereinafter referred to as femoral neck nails). This document applies to femoral neck nails used alone or in combination with other implants such as angle fixators, intramedullary nails, plates, etc. This product is intended for internal fixation of femoral neck fractures during orthopedic surgery.

The contents of the following documents constitute the terms of this document through normative references in the text. Among them, for referenced documents with dates, only the version corresponding to that date is applicable to this document; The version of the referenced document without a date is applicable to this document.

GB 4234.1 Surgical Implants - Metallic Materials - Part 1: Forged Stainless Steel

GB/T 4340.1 Metallic Materials Vickers Hardness Test Part 1: Test Method

GB/T 10610 Geometrical Product Specifications (GPS) - Rules and Methods for Evaluating Surface Structure by Surface Structure Profile Method

GB/T 13810 Titanium and titanium alloy processed materials for surgical implants

GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In vitro Cytotoxicity Test

GB 23102 Surgical Implant Metal Materials Ti-6Al-7Nb Alloy Processing Materials

YY 0018 bone graft implant metal bone screw

YY 0341.1 Passive surgical implants - Bone and spinal implants - Part 1: Special requirements for bone and spinal implants

YY/T 0343 Liquid Penetrant Testing of Surgical Metal Implants

YY 0605.9 Surgical Implants - Metal Materials - Part 9: Forged High Nitrogen Stainless Steel

YY/T 0640 General Requirements for Passive Surgical Implants

YY/T 0662 Mechanical performance requirements and test methods for metal bone screws with asymmetric threads and spherical lower surfaces in surgical implants

YY/T 0856 Metal Angle Fixator for Bone Joining Implants

YY/T 1074 Surgical Implants Stainless Steel Products Pitting Corrosion Potential

YY/T 1504 Test method for axial pull-out force of metal bone screws in surgical implants

YY/T 1505 Test Method for Self tapping Performance of Metal Bone Screws in Surgical Implants

YY/T 1506 Surgical implants - Test method for rotational torque of metal bone screws

The terms and definitions defined in YY 0018 and YY/T 0856, as well as the following terms and definitions, are applicable to this document.

3.1 Metal fixation screw for femoral neck is made of metal material and is used alone or in combination with other implants during femoral neck fracture surgery. It is an instrument implanted in the femoral neck area.

3.2 Axial insertion strength refers to the maximum pressing force required to fully insert the working part of the femoral neck nail implanted into the test block by tapping (see Figure C. 1), in newtons (N).

Overview

This test method specifies the test method for determining the axial insertion force of the femoral neck nail. The femoral neck nail is installed in the installation device, and the universal testing machine applies a compressive load to insert the working part of the femoral neck nail (as shown in Figure C1) into the test block. The maximum compressive force is the axial insertion force.

The purpose of this test method is to provide a test method for determining the axial insertion force of femoral neck nails, for comparison between different types, materials, designs, processes, and surface treatments of femoral neck nails. The results obtained through this test method are not equivalent to the force required for the femoral neck nail to be struck into the human body. The Puchuang experimental device is used to measure the axial insertion force of femoral neck nails, as shown in Figure C-2.

The test apparatus should include: test blocks made of materials that comply with ASTM F1839, their fixtures, and loading devices. At the same time, the test block fixture and loading device should have sufficient rigidity to ignore deformation under the required load conditions.

Test block

The test block shall preferably be made of polyurethane foam material conforming to ASTM F1839. The upper and lower surfaces of the test block should be flat, smooth, and parallel to each other (with a deviation within ± 0.4mm) to ensure that its upper surface is perpendicular to the centerline of the femoral neck nail when it is fixed in the fixture. The test block should be square or other shape that ensures no relative motion or deformation during clamping or testing. The thickness of the test block should be at least 10mm greater than the length of the working part of the femoral neck nail, and the distance between the edge of the insertion position and the edge of the test block should be at least 1.5 times the diameter of the femoral neck nail.

Loading device

A device used to apply compressive load to a femoral neck nail, with the load transmitted through the head of the nail and aligned with the longitudinal axis of the nail. The loading device can rotate freely in the horizontal direction, and friction should be minimized during rotation.

step

Before the experiment, guide holes should be pre drilled in the test block.

Fix the test block and its fixture on the base of the testing machine, and install the femoral neck nail vertically in the testing device. The deviation between the longitudinal axis of the femoral neck nail and the loading axis of the testing machine is ± 1 °.

Insert the working part of the femoral neck nail (see Figure C. 1) into the test block at a speed of 5mm/min, and stop the test after inserting the working part into the test block. Record the load (N) and displacement of the loading device (mm). Determine the maximum compressive force based on the load displacement curve, which is the axial insertion force.

Figure C. Schematic diagram of the working part of the femoral neck nail

Testing instruments:

Test Report

The report should include the following information:

a) Product information of femoral neck nail: manufacturer name, production batch number, model and specifications.

b) Insertion depth;

c) Pre drilled guide hole diameter;

d) For each test sample, record the load displacement curve, the maximum load applied, and whether it failed during the test process;

e) Test block material description: ASTM F1839 grade or density. For materials that do not comply with ASTM F1839, the following should be provided

Information and appropriate measurement methods for determining the material properties of test blocks:

1) Product name;

2) Ingredients;

3) Density;

4) Tensile strength;

5) Compressive strength;

6) Shear strength.