(268 days)
The Fiji Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, and shoulder. The Fiji Anchor is designed only to be inserted with the BoneWelder 150-W1 system. Specific indications are listed below:
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Liqament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
The Fiji anchor system consists of an implantable anchor, an ultrasound system, and handpiece tip, and a twist drill.
The Fiji Anchor® is made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,Llactide. The in vivo degradation of the Fiji Anchor® is based on the natural physiologic process of hydrolysis, which results in the complete metabolization of the polymer into H₂O and CO2.
The Fiji Anchor® is a fully bioresorbable implant designed for soft tissue reattachment to bone by means of suture material. The BoneWelding® technology employs ultrasonic energy to liquefy the polymeric components of the Fiji Anchor® at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone where it is immediately quenched and provides anchorage of the implant.
The ultrasonic energy for the implantation of the Fiji Anchor® is produced by the BoneWelder® ultrasonic generator and applied via the attached handpiece. The handpiece tip (sonotrode) is mounted on the handpiece. It transmits the ultrasonic energy to the Fiji Anchor®. The twist drill is dedicated to be used with the Fiji Anchor®.
This document is a 510(k) premarket notification for the SportWelding GmbH's Fiji Anchor, a medical device for suture or tissue fixation. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria and reported device performance in the context of AI/ML.
Therefore, I cannot extract the requested information from the provided text. The prompt specifically asks about an "AI/ML device" and its performance criteria and study, which is not present in this regulatory submission for a physical surgical anchor.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.