(244 days)
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.