Artelon Convenience Kits

The Artelon Convenience Kits contain implants and instrumentation for soft tissue reinforcement and fixation to bone in surgical procedures. The kits include suture, FlexBand or Twist anchors, FlexBand Dynamic Matrix implants, and instrumentation such as drill bits, tissue protectors, drivers, and drill guides. FlexBand products reinforce soft tissue during tendon and ligament repair; Twist and FlexBand Anchors attach soft tissue to bone in shoulder, knee, foot/ankle, elbow, wrist, and hip procedures.

The subject device (FlexBand and FlexBand Plus) has no changes to indications for use, product codes, principle of operation, or implant materials compared to the predicate. The devices have the same design and range of sizes as the predicate device K230316. Twist anchors have the same range of sizes and similar design as predicate device K200503. An alternative sterilization method using ethylene oxide (EtO) is included in this submission for the subject device kits.

Non-clinical performance bench testing included mesh molar mass characterization, mesh suture retention, mesh tensile testing, anchor pull-out strength, mesh + anchor pull-out strength, anchor insertion and removal torque, and anchor torque to failure testing. Bacterial endotoxin testing, sterilization testing, and packaging testing information were also provided. ISO 13485 quality management system requirements apply.

The Artelon Convenience Kits are substantially equivalent to predicate devices FlexBand, FlexPatch, and FlexBand Plus (K230316) and ATL Anchors (K200503) based on similarities in indications for use, intended use, principles of operation, materials, design, size offerings, shelf life, and product codes. Non-clinical bench testing demonstrated equivalence in performance characteristics, and the evaluation supports that the subject device is as safe and effective as the legally marketed predicate devices.