Sawbones® and Numalogics Achieve First-Ever FDA Qualification of an Orthopedic Device Mechanical Test Under MDDT Program
SEATTLE, WA and MONTREAL, QC – May 20, 2025 — In a groundbreaking advancement for the orthopedic device industry, Sawbones and Numalogics, Inc. are proud to announce that their jointly developed Finite Element Analysis (FEA) model for orthopedic screw pullout testing has received formal qualification from the United States Food and Drug Administration (FDA) through its Medical Device Development Tools (MDDT) program¹. This achievement marks the first-ever FDA qualification of a mechanical test for an orthopedic device, setting a new precedent for virtual testing in regulatory science.