Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

Importancia y uso:

4.1 Absorbable devices are intended to degrade and absorb over time once they are implanted into the body. This makes a removal operation unnecessary, which is especially advantageous for pediatric patients.

4.2 While the polymer degrades due to hydrolytic reaction with the environment, the mechanical performance of the device also deteriorates. The key to developing mechanically effective fracture fixation systems based on absorbable devices is to provide an adequate level of fixation strength and stiffness for a time frame that exceeds that expected for fracture healing. Once the fracture is healed, the device can be completely absorbed by the body. The biological performance of the device, particularly for application at a bony site, may be enhanced by incorporation of bioactive fillers in the polymer.

4.3 Absorbable devices will be tested using test methods that are similar to those used to evaluate conventional metallic devices. The pre-test conditioning requirements, handling requirements, and time-dependent mechanical property evaluations for absorbable devices shall be considered.

4.4 This specification and accompanying test methods are intended to complement the more general considerations for the assessment of absorbable polymeric implants that are described within Guide F2902.

Subcomité:

F04.21

Referida por:

F2902-16E01, F0561-19

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

absorbable; bend testing; bone plates; bone screw; conditioning; dimensions; insertion; pullout; shear; torsion;