Kelyniam Global announced that the NEOS Surgery Cranial LOOP? fixation system has received 510(k) clearance from the FDA for use with Finceramica's CustomizedBone? hydroxyapatite cranial implant. The Cranial LOOP?

family of cranial fixation devices is a smart system made of PEEK-OPTIMA?, a biocompatible polymer, for securely fixing bone flaps after craniotomies. With more than 10 years of market experience, Cranial LOOP? is being used in public and private hospitals in 25 countries worldwide.

Cranial LOOP? was first cleared by the FDA in 2010.  The most recent 510k clearance is for use specifically with Finceramica's CustomizedBone? hydroxyapatite cranial implant. The NEOS Surgery Cranial LOOP? system offers rapid implant fixation in under two minutes using just three devices.

Crafted from PEEK (poly ether ether ketone), it ensures radiolucency for artifact-free imaging (CT and MRI) during post-operative monitoring. Cost-wise, Cranial LOOP? is comparable to traditional plate and screw systems. Kelyniam exclusively distributes CustomizedBone?

implants with the NEOS Cranial LOOP? in the U.S.