Joint replacement and spinal technologies developer Medacta International has secured the US Food and Drug Administration (FDA) clearance for Mpact 3D Metal Implants and Augments 3D Metal as enhancements to its Mpact System for primary to complex hip revision procedures.
Medacta had also stated that the first surgery using the implant and augments was performed this summer at Texas Orthopedics, Sports & Rehabilitation Associates by Tyler Goldberg.
The new implants, Mpact 3D Metal Acetabular Two-Hole and Multi-Hole Shells, are hemispherical porous shells with multiple highly cross-linked polyethylene liner options.
The porous material of the implants are claimed to be ideal for more demanding primary patient cases or in addressing difficult revisions with compromised bone.
These are complemented by the porous 3D Metal Augments, designed to act as defect-filling implant in cases of severe bone loss to help increase the stability of the implant.
They come in a variety of shapes and sizes, giving surgeons intraoperative flexibility to address a wide variety of acetabular defects. Together, these additions strengthen Medacta’s Mpact System and offer surgeons with more options to address complex primary hip replacements and revisions.
The company stated that the Mpact 3D Metal Implants feature its 3D Metal technology, constructed via additive manufacturing using a 3D printer.
This has resulted in enhanced initial stability because of high coefficient of friction at the bone interface and favorable environment for bone without the need for an additional coating.
The 3D Metal Shells and Augments have pore sizes of 600-800 micrometers and continuously interconnected open pores with 75% level of porosity.
Medacta International executive vice president Francesco Siccardi said: “Medacta continues to expand upon its product portfolios as we seek to help our surgeon partners address more patient cases than ever before, whether it’s a complex primary case or a difficult revision.
“With the new Mpact 3D Shells and 3D Metal Augments, our Mpact System offers even greater versatility and continues to instill confidence, thanks to both the high-grade materials used and the built-in surgeon education and support system for which Medacta is well known.”