Indications for Use and Disclaimer

Indications for Use and Disclaimer

MAGELLAN® SYSTEM

FDA 510(k) Indication – BK030040

The MAGELLAN® Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests. The platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site as deemed necessary by the clinical use requirements.

FDA 510(k) Indication – BK040068 

The MAGELLAN® Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of a mixture of blood and bone marrow. The plasma and concentrated platelets produced can be used for diagnostic tests. Additionally, the platelet rich plasma can be mixed with autograft and/or allograft bone prior to application to an orthopedic site.

FDA 510(k) Indication – K041830

The MAGELLAN® Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon’s determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.

FDA 510(k) Indication – K132905

The 200 Micron Blood Component Filter and Syringe Adapter is designed to filter clots and other particles from blood and blood components for delivery.

Disclaimer

The platelet rich plasma prepared by this device has not been evaluated for any clinical indications. Platelet rich plasma prepared from a mixture of whole blood and bone marrow may contain higher levels of plasma free hemoglobin than platelet rich plasma prepared from whole blood.

MAR0Fuse™

Indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. MAR0Fuse™ indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine and pelvis) and as a bone void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.

MAR0Match™

Human musculoskeletal allograft that may be used in a variety of orthopedic, neurosurgical, reconstructive or periodontal procedures. Tissue is processed and freeze-dried and is supplied in a range of sizes for surgical use by licensed clinicians (i.e., physicians, dentists, physician’s assistants, nurse practitioners).  All tissue is processed and packed using aseptic technique.