Kelyniam Global Secures FDA Clearance for New Fusion™ BCP-PEEK Cranial Implant

Kelyniam Global, Inc. has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its Fusion™ Cranial and Craniofacial Implants. 

The devices combine Biphasic Calcium Phosphate (BCP) with Polyether Ether Ketone (PEEK), creating a new material for cranial and craniofacial surgery.

This is the first time the FDA has cleared this material for such applications, marking the first major innovation in this market in eight years. 

The Fusion™ BCP-PEEK implants are designed to promote bone integration while maintaining strength and a personalised fit.

The technology is aimed at custom use in neurosurgery, addressing traumatic injuries, tumour-related defects and congenital abnormalities where precise, patient-specific implants are required. 

Like Kelyniam’s existing PEEK range, the Fusion™ BCP-PEEK implants can be designed, produced and delivered to surgeons within 24 to 48 hours, enabling rapid treatment.

The new implant joins Kelyniam’s broader regenerative product portfolio, which also includes its hydroxyapatite-based CustomizedBone™ implant and Osteopore’s tissue-regenerating products.