(61 days)
LIGAFIX 30 is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (30% β-TCP) and Poly Lactic Acid (70% PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX 30° resorbable cannulated screws are designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
LIGAFIX 30® interference screws are made of a ceramic (30% ß-TCP) / polymer (70% Poly Lactic Acid -PLA) composite.
LIGAFIX 30° interference screws are supplied sterile and individually packaged in double heat sealed pouches.
This document is a 510(k) summary for the LIGAFIX® Resorbable Interference Screw. It describes the device and its intended use, and states that substantial equivalence is based on similar fundamental scientific technology, operating principle, and intended use as a previously cleared predicate device (K050407), with modifications limited to additional screw sizes and a slightly modified head design.
Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission for substantial equivalence based on modifications to an already cleared device, not a performance study.
Thus, I cannot answer the questions as the requested information is not present in the provided text.
§ 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.