(88 days)
The Linvatec UltraFix® Knotless MiniMite® Suture Anchor is intended for reattaching soft tissue to glenoid bone in the shoulder. The following are the indications for use: Bankart lesion repairs, SLAP lesion repairs, capsular shift, capsulolabral reconstructions.
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This document does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The provided text is a 510(k) summary for the UltraFix® Knotless MiniMite® Suture Anchor, which primarily focuses on regulatory approval, device classification, and indications for use, but does not include detailed performance study data.
§ 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.