(23 days)
The T-FIX™ 3DSI Joint Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;
- sacroiliac joint disruptions
- degenerative sacroiliitis
- to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar of thoracolumbar fusion and
- acute, non-acute and non-traumatic fractures involving the sacroiliac joint
The T-FIX™ 3DSI Joint Fusion System, a line extension of the EVOL® -SI Fusion System (K190025), is intended to treat dysfunctions of the sacroiliac joint. The T-FIX™ 3DSI Joint Fusion System includes cannulated, 3D printed, titanium alloy bone screws as well as a full complement of instruments to place them in the body. The T-FIX™ screw is headless so that it may be implanted with a zero profile. The distal portion of the screw has a single lead thread and the proximal end has a double lead thread. T-FIX™ is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis thereby preventing motion of the sacroiliac joint. The T-FIX™ screws are made from a titanium alloy Ti-6Al-4V Grade 23 per ASTM 3001 and offered with a HA nano surface treatment when packaged sterile.
This 510(k) summary does not contain information regarding software or AI/ML components, and therefore does not include acceptance criteria or a study proving device performance in that context. The device described, the T-FIX™ 3DSI Joint Fusion System, is a physical medical device (implants and instruments) for sacroiliac joint fusion, not a software-based diagnostic or therapeutic tool.
The "Non-Clinical and Clinical Performance Testing" section (VIII) refers to "Additional testing was performed to determine that Steam as a sterilization method will not impact the safety or efficacy of this implant," but it does not provide details on specific acceptance criteria or study results for this testing, beyond concluding that it "does not raise any new concerns of safety or efficacy."
Therefore, I cannot provide a table of acceptance criteria and reported device performance (Point 1) or any of the detailed information related to studies proving device performance, as requested in points 2 through 9, because this information is not present in the provided text for this specific device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.