Intramedullary Nails Internal-fixation Pull-out Force Tester

The Intramedullary Nails Internal-fixation Pull-out Force Tester is a specialized device designed to measure the axial pull-out strength of intramedullary nails and internal fixation screws. It evaluates the mechanical anchoring performance of implants in simulated bone or test materials, ensuring their stability and reliability under clinical loading conditions. This tester is widely used in orthopedic research, implant development, and quality control to verify that internal fixation devices can resist dislodgement and provide safe, long-term fixation in patients.

Standard

(1)ASTM F543: Standard specification for metallic medical bone screws (dynamic loading protocols).

(2)ISO 12172: Implants for surgery—Partial and total hip joint prostheses (fatigue testing methodologies).

(3)YY/T 0342: Chinese standard for surgical implant testing (cutout resistance evaluation).

Adaptive Compliance: Customizable protocols for emerging regulatory frameworks.

Product Advantages

(1)Dynamic Load Simulation: Replicates physiological gait-cycle forces (0–1.500 N at 5 Hz) for real-world failure prediction.

(2)Dual-Axis Measurement: Simultaneous tracking of cutout force (N) and angular displacement (°) during cyclic testing.

(3)Failure Prediction Algorithm: Proprietary software identifies pre-failure indicators using machine learning.

(4)High-Speed Imaging Integration: Syncs with external cameras for real-time deformation visualization (optional upgrade).

(5)Ergonomic Workflow: Touchscreen interface with pre-loaded ASTM/ISO templates and customizable test sequences.

(6)Modular Design: Quick-swap fixtures for testing various nail designs (helical blades, lag screws, etc.).

Product Features

(1)Electrodynamic Actuator: Delivers sinusoidal, triangular, or custom waveforms up to 10 Hz.

(2)6-DoF Load Cell: Measures axial/torsional forces and moments with 0.1% FS accuracy.

(3)High-Resolution Motion System: ±5° angular resolution for tracking nail migration paths.

(4)Thermal Stability Chamber: Controls test environment (-20°C to +50°C) for material property analysis.

(5)AI-Powered Analytics: Auto-generates failure mode maps comparing historical/current implant designs.

(6)Remote Access: Cloud-connected system for real-time collaboration and audit trails.

Technical Parameters

Accessories

(1)Dynamic Test Fixture Kit:

Self-centering bone analog holder

Adjustable nail insertion guide (0–45° varus/valgus)

6-Channel Load Cell: Calibrated to ISO 376 standards.

(2)TestMaster Pro Software:

Real-time hysteresis loop visualization

Fatigue life prediction (S-N curve generation)

21 CFR Part 11 compliance module

Safety Enclosure: Acrylic chamber with interlock system and LED lighting.

(3)Calibration Bundle:

NIST-traceable weights (100g–1kg)

Angular verification jig

(4)Operator Kit:

Torque wrench set (0.1–10 Nm)

Sterilizable bone cement spatulas

- ISO international standards: The design, manufacturing, and testing process of the equipment should meet the requirements of ISO international standards to ensure the international recognition of the test results. - National/regional standards: Different countries and regions may formulate specific standards for the mechanical property testing of orthopedic implants. When conducting tests, appropriate national/regional standards should be selected according to the actual situation. - Industry standards: The orthopedic implant industry may also have formulated relevant testing standards and specifications internally. These standards may include provisions on testing methods, testing conditions, testing equipment, etc.

Test Procedures

(1)Secure the intramedullary nail or screw in the testing fixture, simulating bone conditions.

(2)Apply axial load gradually using the machine until pull-out or failure occurs.

(3)Record the maximum force and displacement to evaluate fixation strength.

(4)Repeat tests for multiple samples to ensure consistency and statistical validity.

Maintenance Information

(1)Regularly calibrate load cells and displacement sensors to maintain accuracy.

(2)Keep all moving parts lubricated and free from debris to ensure smooth operation.

(3)Inspect fixtures and clamps for wear or damage before each test.

(4)Store the machine in a clean, dry environment and cover it when not in use.

FAQ

1.What is the purpose of this tester?

It measures the axial pull-out force of intramedullary nails or bone screws to evaluate their fixation strength in simulated bone conditions.

2.Which samples can be tested?

The tester is suitable for intramedullary nails, bone screws, and other internal fixation devices used in orthopedic applications.

3.How is the test performed?

The device gradually applies axial load to the sample until pull-out or failure occurs while recording force and displacement data.

4.What standards does it comply with?

The tester can follow ASTM F543. ISO 12189. and other relevant orthopedic fixation testing standards.

5.How often should the machine be maintained?

Regular maintenance includes calibrating sensors, lubricating moving parts, inspecting fixtures, and keeping the machine clean and dry.