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The MOBIS® Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

The MOBIS® may be implanted singularly or in pairs.

The supplemental internal fixation systems that may be used with the MOBIS® includes, but is not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)

The MOBIS® Spinal implant is the same as the predicate device except that it is supplied with either Titanium or Tantalum marker pins.

This 510(k) premarket notification for the MOBIS® Spinal Implant does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a summary of the 510(k) submission and the FDA's clearance letter, primarily focusing on demonstrating substantial equivalence to a predicate device. It explicitly states:

• "The MOBIS® Spinal implant is the same as the predicate device except that it is supplied with either Titanium or Tantalum marker pins."
• "The MOBIS® Spinal Implant has the same indication for use as the predicate device."
• "The subject device have the following similarities: The same indication for use; The same operating principle; The same basic design; The same materials; Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations."

Based on this, the clearance is granted due to "substantial equivalence" to a previously cleared device (Curved PEEK TETRIS™), rather than through a new performance study with established acceptance criteria. Therefore, the requested information cannot be extracted from the provided text.

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