News, insights - June 2025

Revision knee implant alternative

Zimmer Biomet Holdings Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona Revision SoluTion Femur, a revision knee implant component offering an alternative for patients with sensitivities to certain metals. The Persona Revision SoluTion Femur, part of the comprehensive Persona Revision Knee System, leverages a proprietary surface-hardening treatment designed to enhance wear performance.

The Persona Revision SoluTion Femur is made solely of a proprietary Tivanium (Ti-6Al-4V) alloy with more than 17 years of clinical use. The alloy is treated with the Ti-Nidium Surface Hardening Process, resulting in a strengthened material that demonstrates hardness comparable to metal implants, with enhanced wear performance providing resistance to particle release. The new revision femur is offered in standard and plus sizes to address flexion instability and soft tissue balancing while minimizing implant overhang. https://www.zimmerbiomet.com

FDA expanded use approval

PHOTOS COURTESY OF RESPECTIVE COMPANIES

Miach Orthopaedics Inc. received U.S. Food & Drug Administration (FDA) 510(k) clearance to expand its indication to include children and adolescents of any age, as well as to treat partial ACL tears. The BEAR (Bridge-Enhanced ACL Restoration) Implant enables a torn ACL to heal and restores the natural function of the knee. It’s a paradigm shift from the current standard of care, ACL reconstruction (ACLR), replacing the ACL with a graft.

ACL reconstruction is often a much more complicated procedure in a growing child than in an adult because of their open growth plates. The BEAR Implant offers a more natural solution to ACL injuries and works with a child’s body as the musculoskeletal system continues to develop. https://miachortho.com

AM medical device certification

ABCorp earned ISO 13485:2016 medical device certification for its Additive Manufacturing Center (AMC) in Boston, Massachusetts. ABCorp’s AMC is located within ABCorp’s secure facility, which spans 125,000ft2 and is equipped with multiple HP Jet Fusion 5620 industrial systems, Jet Fusion 580 full-color printers, and Desktop Metal production printers. The range of printed materials includes HP 3D High Reusability PA 11, HP 3D High Reusability PA 12 (including PA 12 White), ForwardAM/BASF Ultrasint TPU01, HP 3D High Reusability PP in collaboration with BASF, full-color HP 3D High Reusability CB PA 12, as well as stainless steels 174PH and 316L. ABCorp provides finishing services using AMT’s PostPro3D smoothing technology. https://abcorp-3d.com

Initial quality certifications

BGS US acquired quality certifications for ISO 13485 and ISO 9001, and the confirmation of ISO 11137 for its 100,000ft2 Electron Beam (E-Beam) sterilization facility in Imperial, Pennsylvania. The facility will begin operations in mid-2025.

The certification audit was conducted by DQS Medizinprodukte GmbH and verified BGS US meets all requirements without any non-conformities.

“This significant milestone marks a crucial step for our company and underscores our commitment to the highest levels of quality and customer satisfaction,” says Leonard Zuba, general manager, BGS US. “It also keeps us on schedule to begin operations as planned.” http://www.bgs-us.com