Silver Bullet Therapeutics Earns Updated CE Mark for Its Antimicrobial Bone Screw System

By Carolyn LaWell

Silver Bullet Therapeutics Earns Updated CE Mark for Its Antimicrobial Bone Screw System

Silver Bullet Therapeutics received a CE Mark for its OrthoFuzIon™ Bone Screw System. The updated mark differs from a similar 2020 CE Mark in that it has no anatomical, clinical or design limitations, according to Founder, President and CEO Paul Chirico.

OrthoFuzIon is reportedly the world’s first antimicrobial bone screw product to achieve regulatory approval for orthopedic procedures. Covered in the company’s proprietary AntiBacterIon™ coating, OrthoFuzIon bone screws release sustained silver ions that protect the device and kill bacteria. In low doses, silver ions are not toxic to humans. OrthoFuzIon Bone Screws are designed for open reduction and internal fixation (ORIF) fracture surgeries and are plated to inhibit microbial colonization and reduce implant-related infection in revision surgery due to implant infection or primary surgery in patients who are at-risk of implant infections.

“This makes our product not only an inherently more commercially viable product line but it is also specifically indicated to help both surgeons and patients that are either at a high risk of infection or subject to revision surgery due to a previous infection and can reduce implant related infection,” Mr. Chirico said.

Tags: CE Mark, Regulatory