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 and/or bone. Device materials that come in contact with nervous tissue, spinal fluid, dura mater or brain often require more comprehensive testing. (See Neurological Devices)
The following information applies primarily to hard implant devices (e.g. bone cement). NAMSA Technical Specialists and Scientists are adept at developing non-clinical programs for these products. Veterinary surgeons on staff are experienced at implanting and/or evaluating the biocompatibility and functionality of such devices.
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 (cancer causing) 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 it's 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.
