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The iFuse Implant System is intended for sacroiliac fusion for the following conditions:

· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.

· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

The iFuse Implant System consists of cannulated triangular, titanium implants Ti-6A1-4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti-6A1-4V ELI, ASTM F3001 with a porous surface and an instrument system. The principle of operation is based on the triangular implant shape and porous surface which are designed to prevent and minimize motion / micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).

This document is a 510(k) Premarket Notification from SI-BONE, Inc. to the FDA regarding their iFuse Implant System®. It is a request for clearance to market an updated version of an existing device, and as such, it does not contain information about a new study with acceptance criteria and device performance as would be found for a novel device or a significantly modified one requiring new clinical data.

Specifically, the document states:

• "There are no changes to the technological characteristics of the device that are the subject of this 510(k)."
• "There were no changes in the design, technological features, intended use and overall risks associated with the iFuse Implant System. Therefore, no new design verification or validation testing was required; the design verification and validation testing previously conducted and submitted in previously cleared SI-BONE 510(k)s is applicable."

Therefore, I cannot provide the requested information from this document. The document explicitly states that no new design verification or validation testing was required for this 510(k) submission. This means there is no new study described within this filing that establishes acceptance criteria and then proves the device meets those criteria.

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The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.

The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. Surgical treatment is accomplished using instrumentation similar to that previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049.

The provided document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

The document is a 510(k) premarket notification for the SI-BONE iFuse Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a de novo study.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: This document states: "No performance data is required to support this Special 510(k)." This indicates that an explicit study with defined acceptance criteria and reported device performance was not part of this specific submission. The substantial equivalence argument relies on the predicate device's established performance, not new performance data for the current device.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, and Training Set Ground Truth: All these items relate to the design and execution of a performance study. Since the document explicitly states "No performance data is required," none of this information is present.

Summary based on the provided document:

The device (SI-BONE iFuse Implant System) is considered substantially equivalent to its predicate devices (SI Joint Fusion System by SI-BONE, Inc. with various K numbers). The basis for this substantial equivalence is that "The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device." Therefore, no new performance data or studies demonstrating specific acceptance criteria for the iFuse Implant System were provided or reviewed in this 510(k) submission.

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