Regulatory - March 2025

Medtech approvals

PHOTOS COURTESY OF RESPECTIVE COMPANIES

Zimmer Biomet Holdings Inc.’s Persona SoluTion Porous Plasma Spray (PPS) Femur, a total knee implant component offering an alternative for patients with sensitivities to bone cement and/or metal, received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Persona SoluTion PPS Femur features a porous coating for cementless fixation and leverages a proprietary surface treatment designed to enhance wear performance.

Persona SoluTion PPS Femur offers cementless fixation with its clinically proven PPS coating providing initial scratch fit stability and supports biologic fixation through bony ongrowth. When combined with Persona OsseoTi tibia and Vivacit-E Highly Crosslinked Polyethylene (HXLPE), the total knee implant minimizes the most common metal sensitizers (nickel, cobalt, and chromium) likely to elicit an immune response and is made of a proprietary Tivanium (Ti-6Al-4V) alloy with more than 17 years of clinical use. The Tivanium alloy is treated with the Ti-Nidium Surface Hardening Process and is compatible with Vivacit-E HXLPE articular surfaces. The Persona SoluTion PPS femur coupled with a Vivacit-E bearing demonstrates similar wear performance compared to a Persona cobalt chromium alloy femur coupled with a Vivacit-E bearing.

Additionally, the OsseoFit Stemless Shoulder System for total shoulder replacement received FDA 510(k) clearance. The implant is designed to match the natural humeral (upper shoulder bone) anatomy to optimize anatomical fit while maximizing preservation of healthy bone. The OsseoFit Stemless Shoulder System expands the company’s total shoulder portfolio and integrates with Identity Humeral Heads with Versa-Dial Technology for infinite offset placement as well as the Alliance Glenoid for a broad range of glenoid options to adapt to a patient’s unique anatomy.

The anatomically designed left- or-right-sided anchor implants feature fins creating a press-fit during insertion and contain fully porous windows. The fin geometry and anchor spacing of the implant determine proper orientation and fit into the natural bone and help avoid cortical impingement, while reaching dense bone areas. In addition, the design includes strategically located anterior reattachment suture holes on the anchor to facilitate subscapularis repair. The system is available in a singular instrument tray to maximize workflow and sterile process efficiency, to fit nicely in a variety of settings including ambulatory surgical centers. https://www.zimmerbiomet.com

PENTAX Medical obtained U.S. FDA 510(k) clearance for new models of the PENTAX Medical i20c Video Endoscope Series – PENTAX Medical Video Colonoscope EC34-i20cL, PENTAX Medical Video Upper GI Scope EG27i20c, and Right/Left Wheel Extender OE-B17.

The new slim models include the signature features of the i20c endoscope generation: advanced imaging, enhanced maneuverability with adjustable stiffness, and superior ergonomics through the new ErgoFeel control body and EasyOn connector. These design updates have the potential to improve the quality of procedures and optimize the clinical workflow.

In addition to the two new endoscope models, PENTAX Medical also received clearance for their add-on Right/Left Wheel Extender, model OE-B17. This reusable piece is attached to the outer right/left wheel of the endoscope to improve accessibility of the outer wheel for endoscopists with smaller hands. https://www.pentaxmedical.com/us