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INDICATIONS (EU and outside of USA)

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

DESCRIPTION

Inion S-1™ Plate and ScrewsThe INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM consists of plates and screws made of degradable co-polymers composed of L-lactic and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. Based on in vitro testing, the implants retain most of their initial strength up to 16 weeks and gradually lose their strength thereafter; and bioresorption takes place within two to four years. The plates and screws contain radiopaque tantalum markers for postoperative radiographic imaging.

The INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are available in different sizes and are designed for use with customised instrumentation, e.g., the INION S-1 drill bits, threading taps, awl, plate holder, drill guides, screw driver, temporary fixation screw, screw removal instrument, plate templates, and a heating device.

The INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are sterile and non-collagenous.

INDICATIONS

The INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM, in conjunction with adjunctive immobilisation (i.e., simultaneous conservative treatment with a collar), is intended for use in anterior cervical discectomy and fusion procedures as a means to maintain the relative position of block bone allografts or autografts. This device is not intended for use in other areas of the spine, and is not for load bearing indications.

CONTRAINDICATIONS

The INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM implants are not intended for use in, and are contraindicated for:

  • Active or potential infection

  • Cancer

  • Pseudoarthrosis

  • Patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse)