MagnetOs MIS

MagnetOs MIS is a synthetic, resorbable bone void filler consisting of ceramic granules (65-75% tri-calcium phosphate and 25-35% hydroxyapatite) premixed with a polymeric binder. It is supplied in a 5cc pre-filled cartridge with a delivery system kit and is intended to fill bony voids or gaps in the skeletal system (extremities, pelvis, intervertebral disc space, posterolateral spine) from surgical or traumatic defects. The material resorbs and is replaced by bone during healing.

The delivery system kit and pre-filled cartridge design are identical to the primary predicate (NovaBone Putty MIS). The ceramic granules are identical in size and composition to those in additional predicates (MagnetOs Easypack Putty and MagnetOs Putty). The polymeric binder is identical to MagnetOs Easypack Putty. Both subject and predicate devices contain granules pre-mixed with a resorbable synthetic polymeric binder.

ASTM F2096 (Gross bubble leak testing), ASTM F88 (Seal strength testing), Ph.Eur. 2.6.14 (Bacterial Endotoxins test via Limulus amebocyte lysate gel clot method), and USP <85> (Bacterial Endotoxins).

MagnetOs MIS shares identical intended use and indications for use with its predicates. The delivery system and cartridge design are identical to NovaBone Putty MIS, and the graft material composition (ceramic granules and polymeric binder) mirrors the predicates' formulations. Minor technological differences do not raise different safety or effectiveness questions. Animal and clinical data from previous clearances of the predicate devices support equivalence, as recommended in FDA's Class II Special Controls Guidance for this device category.