(28 days)
The Arthrex 2.4 mm Knotless Hip SutureTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.
The Arthrex Knotless Hip SutureTak® Suture Anchor is a non-absorbable, “tap-in" suture anchor with a barbed profile and a proximally placed external suture eyelet. The anchors are preloaded with Arthrex Suture and are offered preassembled on an inserter. The device is single-use.
This document describes the 510(k) premarket notification for the "Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor". It is not an AI/ML medical device, but rather a surgical implant.
Therefore, the requested information (acceptance criteria for an AI/ML device, details of an AI/ML study, sample sizes, expert qualifications, etc.) is not applicable to this document.
The "Performance Data" section in the document refers to mechanical strength testing and bacterial endotoxin testing for a physical medical device, not the performance of an AI/ML algorithm.
§ 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.