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Classified in: Health
Subject: FDA

Camber Spine Technologies Announces 510(k) Clearance For Their Siconustm SI Joint Fixation System


WAYNE, Pa., Jan. 23, 2017 /PRNewswire/ -- Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconustm SI Joint Fixation System. Siconustm becomes the second product in the Camber Spine Technologies portfolio to treat sacroiliac disease, as a complement to the Prolixtm custom machined allograft implant.

"The Siconustm SI Fusion Screw System is an important addition to our growing portfolio of devices and completes our exclusive SI Fusion product portfolio." said Daniel Pontecorvo, Founder and CEO of Camber Spine Technologies.  "Siconustm provides superior compression across the SI Joint over multiple turns of the threaded fixation implants.  When used with the Prolixtm 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.  The combined solution may be the only MIS SI Joint Fusion technology to foster a True Fusion of the SI Joint."

The Siconustm SI Fixation System is intended to provide fixation and stabilization of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of the degenerative sacroiliitis, or sacroiliac joint disruptions.

Siconustm was developed under a collaborative agreement with the Institute for Musculoskeletal Science & Education (IMSE), an independent, full-service product development and engineering services company.

About Camber Spine

Camber Spine Technologies, LLP, is a fast-growing musculoskeletal implant company founded in 2010 bringing innovative, best-in-class products to the market, providing surgeons and their patients with better treatment options. The company is committed to delivering surgeon inspired new technologies to the spine market. Camber is an ISO 13485 certified medical device company. Camber Spine Technologies, located in Wayne, Pennsylvania, markets a line of proprietary musculoskeletal products nationwide through its exclusive distributor, S1 Spine. For further information please visit www.cambermedtech.com. For inquiries about Siconustm or distribution opportunities please call 484.427.7060.

All of Camber Spine Technologies' products are proudly MADE IN THE USA.

SOURCE Camber Spine Technologies


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