FDA Grants De Novo Classification for BONESUPPORT’s CERAMENT G

The U.S. Food and Drug Administration (FDA) has granted De Novo classification to CERAMENT G.

CERAMENT G is, according to FDA documents, classified as a Class II device under the generic descriptor “resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial.” This type of device is a “resorbable implant intended to fill bony defects of the extremities where there is an increased risk of infection. It is intended to resorb over time and be replaced by new bone. The product is intended for reduction of recurrence of chronic osteomyelitis of long bones. It is not intended to treat infection.”

CERAMENT G is, according to FDA documents:

• A resorbable, gentamicin-eluting ceramic bone void filler intended for use as a bone void filler in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement (standard treatment approach to a bone infection) as part of the surgical treatment of osteomyelitis in defects in the extremities. By eluting gentamicin, CERAMENT G can reduce the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms in order to protect bone healing.
• Indicated for use to augment provisional hardware to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
• A bone void filler which resorbs and is replaced by bone during the healing process.

The De Novo request process provides a marketing pathway for truly novel (meaning that, according to the FDA regs, no legally marketed predicate device exists) medical devices.

Lund, Sweden-based BONESUPPORT AB, an orthobiologics company focused on developing solutions for patients with bone disorders, submitted the De Novo request to the FDA. According to BONESUPPORT, this filing was supported by “extensive laboratory testing, animal studies, and a robust clinical study of CERAMENT G.”

Since 2016, BONESUPPORT has worked with Washington, DC-based MCRA, LLC for its regulatory needs. MCRA is a consulting firm as well as a medical device and biologics Clinical Research Organization (CRO).

In the press release, MCRA Vice President of Orthopedic Regulatory Affairs Hollace Rhodes said, "We were pleased to work with BONESUPPORT's team to bring this Breakthrough technology to the U.S. market.”

Rhodes continued, “For the first time, patients in the U.S. will have access to CERAMENT G and its one-stage solution to osteomyelitis.”