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FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized.

FairFix Extender is intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.

The subject FairFix Adjustable Button System Extension is a Medacta SportsMed devices line extension providing two new implantable fixation devices with an adjustable suture loop used during knee ligament reconstruction surgery for the fixation of the graft by means of an extra cortical suspensory fixation.

Specifically, the current submission includes:

• FairFix AM Adjustable Button, a metal button with a pre-assembled, nonabsorbable . adjustable suture loop to be coupled with the graft, a pulling suture (blue) to pull the construct through the bone tunnel and a flipping suture (white) to flip the button once the extracortical side has been reached; and
• FairFix PSP Adjustable Button, an extra-cortical fixation device pre-assembled with a non-. absorbable adjustable suture loop indicated for the extracortical fixation of the graft on the tibial side.

Both the devices are provided pre-assembled on a dedicated card, aiming to facilitate device handling and connection to the graft.

This document describes the FDA's decision regarding the 510(k) premarket notification for the FairFix AM Adjustable Button and FairFix PSP Adjustable Button. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested.

The document indicates that Medacta International SA claimed substantial equivalence to predicate devices (FairFix Adjustable Button System, K203259, and M-ARS ACL, K171640) based on technological characteristics and performance data.

Specifically, it states:

• "No clinical studies were conducted."
• "Based on the risk analysis, performance testing was conducted to written protocols." The listed non-clinical studies include:
  • FairFix Design Validation, Cadaver Lab
  • FairFix AM Adjustable Button Mechanical Behavior Validation Rationale
  • FairFix PSP Adjustable Button Mechanical Behavior Validation Rationale
  • MR safety evaluations
  • PYROGENICITY (Bacterial endotoxin test and Pyrogen test)
  • BIOCOMPATIBILITY evaluation
  • SHELF-LIFE evaluation

Without access to the specific "written protocols" and results of these performance tests, it is not possible to extract the requested information in the provided format. The document only confirms that these tests were performed to support substantial equivalence, but not the specific acceptance criteria or detailed results.

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