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510(k) Data Aggregation
K Number
K171228Device Name
Fiji Anchor
Manufacturer
Date Cleared
2018-01-19
(268 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SportWelding GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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
Device Description
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®.
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