More than 9,000 CustomizedBone implants have been integrated into patients. Credit: Gorodenkoff/Shutterstock.com.

Kelyniam Global and Finceramica Faenza have announced the Food and Drug Administration (FDA) 510(k) clearance for the NEOS Surgery Cranial LOOP fixation system to be used with the latter’s CustomizedBone hydroxyapatite cranial implant.

The Cranial LOOP system, crafted from PEEK-OPTIMA, a biocompatible polymer, is designed for the secure fixation of bone flaps following craniotomies.

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With over a decade of market presence, the system is utilised in both public and private hospitals across 25 countries.

The recent FDA clearance specifically endorses the compatibility of Cranial LOOP with the CustomizedBone hydroxyapatite cranial implant.

Since its introduction in 2004, more than 9,000 CustomizedBone implants have been integrated into patients, owing to hydroxyapatite’s bone-like properties that promote osteo-integration.

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CustomizedBone is noted for its low infection risk and is suitable for use in children as young as seven years old.

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The NEOS Surgery Cranial LOOP system offers a quick implant fixation process, taking less than two minutes and requiring only three devices.

PEEK’s radiolucency ensures that the Cranial LOOP system does not interfere with CT and MRI imaging, allowing for clear post-operative monitoring. In terms of cost, it is on par with conventional plate and screw systems.

In the US, Kelyniam is the exclusive distributor of CustomizedBone implants paired with the NEOS Cranial LOOP system.

Kelyniam CEO Ross Bjella said: “This approval will further boost Kelyniam’s sales momentum which started in Q4 last year.

“Alongside the low infection rate and paediatric indication, the rapid fixation provided by the Cranial LOOP system is now an added benefit for neurosurgeons choosing CustomizedBone for their patients.”

Finceramica Faenza, a spin-off from the Institute for Science and Technology for Ceramics (ISTEC-CNR) in Faenza, Italy, is now part of the Tampieri Financial Group.

It is known for its integration of ceramics and biomedical science, creating organic material-based medical solutions that support bone and cartilage repair and facilitate rapid recovery.