Medacta International received FDA 510(k) clearance for its Mpact 3D Metal Implants and Augments 3D Metal as enhancements to its Mpact System for primary to complex hip revision procedures.
Here are five things to know:
1. The new Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells are hemispherical porous shells with multiple highly cross-linked polyethylene liner options. The porous 3D Metal Augments are designed to act as a defect-filling implant in cases of severe bone loss to increase implant stability.
2. Medacta's proprietary 3D metal technology is designed to enhance initial stability due to a high coefficient of friction at the bone interface.
3. The 3D Metal Shells and Augments feature pore sizes of 600 to 800 micrometers and interconnected open pores with a high-porosity level of 75 percent.
4. Tyler Goldberg, MD, of Austin-based Texas Orthopedics, Sports & Rehabilitation Associates performed the first U.S. surgery using the implant and augments. Dr. Goldberg used the Mpact Two-Hole shell in his primary case.
5. The Mpact 3D Metal Implants and Augments are designed to be compatible with several surgical techniques, including Medacta's Anterior Minimally Invasive Surgery hip replacement approach.