Medacta Gains FDA Clearance, Announces First U.S. Procedure for Hip Implants

By Julie A. Vetalice

Medacta received FDA 510(k) clearance to market its Mpact 3D Metal implant and Augments 3D Metal for use in total hip arthroplasties or revision procedures.

The company subsequently announced completion of the first U.S. procedure with the implants and augments.

Mpact 3D Metal Acetabular Two-Hole and Multi-Hole implants are enhancements to the Mpact® hip system. They are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. Mpact 3D Metal implants are additively-manufactured with Medacta’s proprietary 3D Metal technology. This technology, according to the company, provides enhanced initial stability due to a high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating.

The porous 3D Metal Augments are designed to act as a defect-filling implant in cases of severe bone loss. The augments come in multiple shapes and sizes, allowing for intraoperative flexibility to address a range of acetabular defects.

Mpact 3D Metal Implants and augments are compatible with several surgical techniques, including Medacta’s Anterior Minimally Invasive Surgery (AMIS®) approach.

Source: Medacta

Product Labels: Hip Replacement

Tags: 510(k) Clearance, Regulatory