(71 days)
The Silex Sacroiliac Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
The Silex Sacroiliac Joint Fusion System consists of bone screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The Silex system is manufactured from Titanium alloy in accordance with ASTM F136, and the larger diameter (12.5mm) implants may optionally have the exterior surfaces plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. Silex implants are intended for single use only and should not be reused under any circumstances. The implants and associated components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
The provided 510(k) summary for the Silex™ Sacroiliac Joint Fusion System does not contain any performance data from a study demonstrating the device meets specific acceptance criteria.
The document explicitly states:
"No performance testing was required to support the modifications for Use as there are no changes to the technological characteristics of the device."
This K140079 submission is for a modification to the Indications for Use (IFU) of an already cleared device (K123702). Therefore, the substantial equivalence was based on a comparison to predicate devices, focusing on:
- FDA Product Code
- Indications for Use
- Surgical Approach
- Anatomical Region
- Implant Materials
- Product Dimensions
Without performance testing, no acceptance criteria table or information related to a study proving the device meets them can be extracted from this document. Each point of your requested information relies on the existence of such a study, which is absent here.
§ 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.