2024-19726. Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device

Table 1—Intervertebral Body Graft Containment Device Risks and Mitigation Measures

Identified risks to health	Mitigation measures
Adverse tissue reaction	Design characteristics, Biocompatibility evaluation, Sterilization/reprocessing validation, and Labeling.
Infection	Sterilization/reprocessing validation and Labeling.
Loosening/migration due to device failure or failure at the bone-implant interface	Design characteristics, Clinical performance testing, Non-clinical performance testing, Biocompatibility evaluation, and Labeling.
Tissue injury	Labeling.
Pseudarthrosis due to device failure or failure at the bone-implant interface	Clinical performance testing, Non-clinical performance testing, Biocompatibility evaluation, and Labeling.
Adverse clinical sequelae	Clinical performance testing and Labeling.
Use error/Improper device use	Labeling.