Nvision Gains FDA Clearance for PEEK Hammertoe System

By Julie A. Vetalice

Nvision Biomedical Technologies received FDA 510(k) clearance to market Vector™, the first foot/ankle implant made from PEEK-OPTIMA™ HA Enhanced polymer from Invibio Biomaterial Solutions. The device is also reportedly the first lower extremity implant to use Structural Encoding® to enable Unique Device Identification.

Structural Encoding, licensed from Watershed Idea Foundry, is able to embed the entire history of the device; this data can be read by simple x-ray imaging.

This clearance represents Nvision's entry to the extremities trauma market, expanding from its previous focus on spine. Vector enables a standard surgical technique that allows direct drilling and exact placement of the implant, and is an alternative to the conventional K-wire implant procedure to treat hammertoe.

Source: Nvision Biomedical Technologies

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory