Nvision Biomedical Technologies has received the US Food and Drug Administration (FDA) approval for the first use of PEEK-OPTIMA HA Enhanced with its Lapidus and Subtalar Fusion Wedges.
PEEK-OPTIMA HA Enhanced is a spinal device technology used for material enhancement.
Developed by Invibio Biomaterial Solutions, the polymer is said to promote multi-directional bone healing and allows for improved fixation.
The Lapidus and Subtalar Fusion Wedges, part of the expanded Trigon product line, mark the company’s fifth and sixth medical devices to use PEEK-OPTIMA HA Enhanced.
Nvision product development senior vice president Tom Zink said: “We are always looking at new ways to address different foot and ankle procedures that will benefit the patient and surgeon.
“By taking an innovative approach to marrying the best materials, manufacturing platforms, and engineering science, we are changing the conversation around foot and ankle surgery.”
The FDA approval indicates Trigon Lapidus Wedge as a PEEK-OPTIMA HA Enhanced implant for a first metatarsal-cuneiform lengthening arthrodesis.
According to the company, Trigon Lapidus Wedge is the first implant to specifically reference lengthening in its FDA indication.
The wedge is offered in three footprint sizes, with several lengths restoring thicknesses and variations in sagittal and transverse angle correction.
In addition, the system comes with a triplanar correction feature, where a jerk allows for frontal plane rotation, along with the ability to restore and maintain the length of the first metatarsal.
Trigon Stand-Alone Subtalar Wedge has a 25mm diameter and offers correction heights ranging from 6mm to 16mm in parallel and angled options.
Its PEEK-OPTIMA HA Enhanced material has a modulus similar to bone and allows artifact-free imaging and provides an osteoconductive surface for bone on-growth, said Nvision.
Established in 2013, Nvision is a large-scale medical device manufacturer based in San Antonio, US, with 23 FDA approved devices across different orthopaedic specialities.
In the last four months, Nvision enhanced its portfolio with four FDA approved products, with one currently being reviewed by the FDA and two others scheduled for submission.
