From a biocompatibility perspective, orthopedic devices can be examined as solid implant types made from polymers, ceramics, and metals, and as pastes or two-part systems that require mixing in situ before implant. Such devices are quite varied and can overlap with neurological devices when used in the vertebrae or as a skull replacement material. What these devices have in common is that all contact muscle or bone. Device materials that come in contact with nervous tissue, spinal fluid, dura mater, or the brain often require more comprehensive testing.
The following information applies primarily to hard implant devices (e.g., bone cement). Our technical specialists and scientists are adept at developing non-clinical programs for these products. Veterinary surgeons on staff are experienced at implanting and evaluating the biocompatibility and functionality of such devices.
Our extensive experience with orthopedic devices includes spinal devices such as injectables, fusion devices, fixation devices, and orthobiologics. While some orthopedic devices may be short term or “externally communicating,” the majority are long-term implants. Depending upon the exact nature of the materials in the orthopedic device, testing concerns can be significant. This is a device category where one must also consider the carcinogenic potential of the device materials.
Standards and Regulation
First consideration should be given to vertical standards (an FDA guideline or ISO standard in use for a specific device). In the absence of such guidance, ISO 10993 should be consulted to determine potential areas of concern for these devices.
Each device should be examined on its own merits. In some cases, prior data may be available from suppliers or in the literature, or there may be efficacy or functionality testing in progress that may be used to satisfy a portion of the safety requirements.
Our experience in orthopedic therapies spans all manner of indications, therapies, and technologies.
NOTE: This list provides an overview of tests that should be considered for orthopedic devices—our technical specialists and scientists will partner with you to develop specific, cost-effective test programs that minimize your time to market.