Kelyniam Global Announces 510(k) Clearance for Integrated Fixation System for Custom Skull Implants

LG Thin-Clients Feature Built-in RFID Capabilities Optimized for Use in Healthcare Facilities

Supporting its mission to help healthcare providers streamline operations and deliver exceptional patient care, LG Business Solutions USA introduced a new LG thin client...

Experien Group Acquired by Veranex

Veranex combines product development, regulatory, and market access expertise — globally and across complex and emerging markets.

Kelyniam Global (KLYG), a maker of custom cranial and craniofacial implants, announced today that it has received premarket approval from the Food and Drug Administration (FDA) for a new 510(k) application that allows for unique modifications to their PEEK cranio-maxillofacial implant product line.

Custom Skull ImplantsThis approval means Kelyniam can now sell the only approved PEEK cranial implant with an integrated fixation system (IFS).  IFS Tabs© can eliminate the need for cranioplasty plates, saving hundreds of dollars per procedure. Surgeons can determine where the fixation tabs are placed around the implant to ensure a precise fit.

The comprehensive 510(k) application included additional modifications that are now only available on Kelyniam’s PEEK implants.  Eric Boyea, Director of Quality and Regulatory Affairs, said, “Kelyniam has a proven process for 510(k) submissions and worked closely with the FDA to ensure the review process went smoothly.  We are excited about this approval because surgeons can now request Kelyniam implants to include a temporal cutback to help streamline implantation by reducing the need for difficult dissection when needed.  Surgeons also have the option to include perfusion holes to allow communication with the subgaleal space when needed.”

Dr. Mark Smith, Kelyniam’s VP of Business Development said, “I know from first-hand experience and from discussions with colleagues just how much easier and faster securing the implant is with the IFS Tabs©.”

“Our distributor partners have been eagerly waiting for this approval,” said Laura Reed, Kelyniam’s National Sales Director.  “These unique enhancements, many which are now only approved for Kelyniam implants, will differentiate our products in the market.  In addition, these new features can be included within our current 24-hour turnaround time.”

Ross Bjella, Kelyniam’s Chairman and CEO, said, “Kelyniam has once again proven our ability to work closely with surgeons and the FDA to bring innovative products to the market. Our commitment to providing unique products that meet or exceed customer needs is evident in this comprehensive application.”

Kelyniam expects to start shipping the enhanced implants in June.

spot_img

DON'T MISS

Graham Belgrave Named to the 2021 PharmaVOICE 100 List of Distinguished Leaders

At Advanced Clinical, and from previous organizations, Belgrave serves as a mentor to several colleagues, where he challenges them to think outside of the box and take risks.

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.