(69 days)
The AperFix™ Tibial Implant with Inserter is intended for use with soft tissue grafts to provide tendon to bone fixation during arthroscopic or open ACL reconstruction procedures.
The AperFix Tibial Implant is a device that provides soft tissue compression within the prepared tibial tunnel to anchor the tendon. It includes a screw and a two-part screw sheath. AperFix Tibial Implants are available in diameters of 9, 10 and 11 mm with a standard length of 30 mm. Each AperFix Tibial Implant is supplied with the implant screw pre-loaded on a disposable inserter. The role of the inserter is to assist in implant placement within the tibial tunnel.
The AperFix Tibial Implant screw and sheath are manufactured from PEEK-OPTIMA** LT (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc.
The provided text is a 510(k) summary for the AperFix™ Tibial Implant with Inserter, a medical device for bone fixation. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it refer to an AI/ML device.
Therefore, I cannot provide the requested information in the specified format because the input utterly lacks the descriptions of acceptance criteria, device performance, sample sizes, provenance, expert qualifications, ground truth establishment, or any details related to a clinical study or AI/ML algorithm evaluation.
The document is purely administrative, detailing the device's classification, intended use, and a declaration of substantial equivalence to predicate devices, which is a regulatory pathway for approval, not a performance study.
§ 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.