Kelyniam of Canton, Connecticut received FDA clearance to sell its custom skull implants for filling of bony voids in the cranium. Using patient CT scans, the company Individually manufactures each implant out of Invibio’s PEEK-OPTIMA polymer with a turnaround time of around 24 hours.
• Engineered for strength, stability and biocompatibility
• Radiolucent (minimal MRI artifact)
• Proven and unparalleled stiffness and strength
• Surgeon may use any plating system for placement during surgery
• Lightweight
• Autoclavable – can withstand repeated sterilization
• Minimum thickness of implant is 3mm
• Attached to native bone with commercially available cranioplasty fastener systems
Press release: Kelyniam Receives FDA 510(k) Clearance to Market Cranial Implants…
Kelyniam Custom Skull Implants brochure…