FDA 483 - OrthoFundamentals, Llc - May 20, 2025

An FDA inspection of OrthoFundamentals, Llc identified significant deficiencies across multiple quality system areas. The firm failed to adequately establish procedures for design control, complaint handling, corrective and preventive actions, risk analysis, and supplier management. These issues led to inadequately validated design changes for their Trellis SI Joint Fusion System, insufficient investigation of complaints, and a lack of robust processes for identifying and mitigating risks.