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