The ALMAS device, class IIb medical device, is a system of cervical disc associated with a surrounding ring which are intended to be implanted and assembled on the spine via anterior approach in order to achieve a cervical disc arthroplasty between two vertebras. Cervical disc arthroplasty aims to reduce
significantly and sustainably patient’s pain and disability while, unlike fusion, preserving neck mobility. This surgery, performed by orthopedic surgeons or neurosurgeons on skeletally mature patients, is conducted in the cervical region of the spine. Specific implants have been designed, developed and
distributed by Novaspine for this treated area. Medical indications, contraindications, general adverse events, lifetime and safety measures are gathered in the IFU provided with the ALMAS system.

Performance claims focuses on disc height recovery, pain reduction and disability reduction, while safety claims concern disc breakage, migration and subsidence rates. All the ALMAS products have been CE marked and implanted since 2008.

Device Description

ALMAS Cervical Disc System is a mobile disc prosthesis for the cervical region to treat spinal
pathologies while conserving neck mobility:

The design is a combination of the anatomical shape of the cages and the mobility of the intersomatic discs. The anatomical shape of the ALMAS disc is intended to ensure good adaptation between the implant surface and the vertebra endplate, and mobility is intended to ensure the physiological function of the spine. To ensure optimal security and prevent a possible migration of the implant outside its site of implantation, a titanium surrounding ring is added to surround the disc without affecting his mobility. The whole system aims to prevent an adjacent level syndrome (onset of discopathy and monosegmental instability).