Musculoskeletal implant firm Camber Spine Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Siconus SI joint fixation system.
The system has been developed to provide fixation and stabilization of large bones such as sacrum and ilium.
It can be used in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.
The company developed the Siconus system as part of a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE).
IMSE is an independent and full-service product development and engineering services company.
The new system is said to compliment Prolix custom machined allograft implant, expanding the treatment solutions for sacroiliac disease.
Camber Spine Technologies founder and CEO Daniel Pontecorvo said: “The Siconus SI Fusion Screw System is an important addition to our growing portfolio of devices and completes our exclusive SI Fusion product portfolio.
“Siconus provides superior compression across the SI Joint over multiple turns of the threaded fixation implants.
“When used with the Prolix SI Joint Fusion System, the combined solution offers a direct visualization and insertion of a machined allograft spacer into the SI joint, followed by a lateral approach compression and fixation implants.”
Based in Wayne of Pennsylvania, Camber Spine markets its musculoskeletal products through its exclusive distributor S1 Spine.