There is currently no ASTM F2624 compliant test fixture or method at SeaSpine, a local San Diego based spinal implant company. The ability to consistently test a versatile range of spinal products is integral to the product development cycle. However, a majority of the information regarding testing fixtures remain as proprietary company information. This leads many companies to rely on 3rd party testing companies to validate their products, which can add time and extra expense to the product development cycle.

Companies that can test in-house maintain a competitive edge, however, this means that companies such as SeaSpine are limited by the resources available in-house. Furthermore, testing methods and fixtures that comply with ASTM F2624 standards must be specialized to interface with the available testing setups at SeaSpine. Developing a standard fixture for spinal tests compliant with ASTM F2624 specifications would also address the lack of standardization in spinal implant development with regard to proper testing setups.

The main goal for this project is developing ASTM F2624 compliant testing fixtures that are both compatible with SeaSpine’s testing setups, and which can validate a variety of implants.

1. Test fixture(s) must perform tests in compliance with ASTM F2624 standard such that all configurations can be properly tested.
   

2. Test fixture(s) must be able to withstand in-vivo simulation testing, being able to perform in a bovine solution that mimics in-vivo conditions.
   

3. Test fixture(s) must be able (or adaptable) to test a large variety of extra-discal single-level spinal implants, not just limited to SeaSpine’s current spinous process implant.