(43 days)
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Various style titanium alloy and stainless steel screws and washers. Screw diameters range from 3.5mm to 6.5mm and 10mm to 60mm in length. Washers have posts or spikes to engage the bone.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter for the "WasherLoc™ Screw System" and related soft tissue fixation screws. It discusses the regulatory classification, intended use, and general controls provisions of the Medical Device Amendments, but it does not detail any specific performance acceptance criteria or the results of a study designed to demonstrate them.
§ 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.