The Food and Drug Administration (FDA) has cleared Cerament G for use as a bone void filler in skeletally mature patients as an adjunct to systemic antibiotic therapy and surgical debridement as part of the surgical treatment of osteomyelitis.

Cerament G is a resorbable, gentamicin-eluting ceramic bone graft substitute consisting of hydroxyapatite, α-calcium sulfate hemihydrate, and the aminoglycoside antibiotic gentamicin sulfate. The combination allows for natural bone healing, while reducing the recurrence of chronic osteomyelitis from gentamicin-sensitive microorganisms. Cerament G resorbs and is replaced by bone during the healing process; the cured paste acts as a temporary support media.

“The benefits of Cerament G for patients and clinics, have been validated in several very strong clinical trials, and have paved the way for our strong sales in Europe, where Cerament G accounts for a clear majority of our sales,” said Emil Billbäck, CEO of BONESUPPORT.

The FDA has classified Cerament G a Class II device under the generic name resorbable calcium salt bone void filler containing a single approved aminoglycoside antibacterial. It is intended for reduction of recurrence of chronic osteomyelitis of long bone, but not to treat infection.

The use of Cerament G is contraindicated in patients with myasthenia gravis, severe renal impairment, pre-existing calcium metabolism disorder, and in patients who are pregnant or breastfeeding.

References

  1. BONESUPPORT receives market authorization for CERAMENT G in the US. News release. BONESUPPORT. Accessed March 16, 2022. https://www.bonesupport.com/en-eu/media/press-releases/bonesupport-receives-market-authorization-for-cerament-g-in-the-us/
  2. US Food and Drug Administration, Center for Devices and Radiological Health (CDRH). BONESUPPORT AB; Re: DEN210044 letter. May 17, 2022. Accessed May 20, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf21/DEN210044.pdf
  3. CERAMENT G: Product Fact Sheet. BONESUPPORT. Accessed May 20, 2022. https://www.bonesupport.com/wp-content/uploads/2021/03/935.-PR-0935-02-en-EU-2020-10-CERAMENT-G-Product-Fact-Sheet.pdf
  4. Products: CERAMENT G. BONESUPPORT. Accessed May 20, 2022. https://www.bonesupport.com/en-eu/products/cerament-g/