ASTM F2624-12
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

Standard No.

ASTM F2624-12

Release Date

2012

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2624-12(2016)

Latest

ASTM F2624-12(2020)

Scope

This test method is designed to quantify the static and dynamic characteristics of different designs of single level spinal constructs. Wear may also be assessed for implants that allow motion using testing medium (see 6.1) for simulating the physiologic environment at 37°C. Wear is assessed using a weight loss method in addition to dimensional analyses. Weight loss is determined after subjecting the implants to dynamic profiles specified in this test method. This information will allow the manufacturer or end user of the product to understand how the specific device in question performs under the test conditions prescribed in this test method.

This test method is intended to be applicable for single level extra-discal spinal constructs. Three different types of fixtures are specified for testing single level extra-discal spinal constructs (See Fig. 2, Fig. 4, and Fig. 5). See also Table 1.

Implants may be designed using a variety of materials (for example, ceramics, metals, polymers, or combinations thereof), and it is the goal of this test method to enable a comparison of the static, dynamic, and wear properties generated by these devices, regardless of material and type of device.

TABLE 1 Loading Modes and Associated Apparatus Listing Possible Tests That May Be Conducted (see 1.9)

Note 18212;For all loading modes, static, dynamic, and wear tests are described in this test method.

Note 28212;“Offset” refers to 8 mm of offset induced in the spinal construct (see Fig. 6) before subjecting the construct to rotational flexion/extension moments (see Fig. 2).

Associated Apparatus	Associated Figure	Loading Mode
Rotational	Fig. 2	Flexion
		Extension
		Lateral Bending
		Axial Rotation
	Fig. 2 and Fig. 6	Offset Flexion and Offset Extension
Shear	Fig. 4	Anterior/Posterior Shear
Compression Bending	Fig. 5	Compression Bending

FIG. 4 Schematic of Anterior/Posterior Shear Testing Apparatus

FIG. 5 Schematic of Single Level Compression Bending Test

1.1 This test method describes methods to assess the static and dynamic properties of single l......

ASTM F2624-12 history

• 2020 ASTM F2624-12(2020) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• 2016 ASTM F2624-12(2016) Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• 2012 ASTM F2624-12 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• 2007 ASTM F2624-07 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Spinal Motion Preserving Implants