OssDsign Announces FDA 510(k) Clearance of OSSDSIGN® Cranioplug
Designed with a ceramic material component that resorbs and is replaced with bone during the healing process
UPPSALA, Sweden, October 22, 2018 (Newswire.com) - OssDsign AB, the Swedish designer, manufacturer and distributor of regenerative implants for cranial and facial reconstruction, today announced that it has received 510(k) clearance by the US FDA for marketing and sale of its latest product, OSSDSIGN® Cranioplug.
OSSDSIGN® Cranioplug is an implant used during neurosurgical procedures, and it is made from an osteoconductive calcium phosphate ceramic composition reinforced with a titanium mesh plate.
Manufactured from the same unique calcium phosphate composition as other OssDsign implants, OSSDSIGN® Cranioplug is the first product of its kind in the US market. The osteoconductive ceramic component of OSSDSIGN® Cranioplug resorbs and is replaced with bone during the healing process.
Anders Lundqvist, CEO of OssDsign, said: “Receiving clearance for Cranioplug is an important step for OssDsign. This motivates us to increase our presence in the US market and continue to build our US organization throughout 2018 and beyond. The regenerative features of OssDsign’s calcium phosphate composition are now getting recognized, and it’s our mission to turn them into real benefits for patients, surgeons, and hospital systems.”
OSSDSIGN® Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.
For further information, please contact:
Anders Lundqvist, CEO, OssDsign AB
Phone: +46 73 206 98 08, email: email@example.com
OssDsign is a Swedish medtech company dedicated to creating regenerative implants for improved healing of bone defects. OssDsign provides neurosurgeons and reconstructive plastic surgeons around the world with an expanding range of innovative implant solutions for improved patient outcomes. OssDsign’s technology is the result of collaboration between clinical researchers at the Karolinska University Hospital, Stockholm, and material science experts at the Ångström Laboratory at Uppsala University.
Source: OssDsign AB