FairFix AM Adjustable Button FairFix PSP Adjustable Button

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K221389 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What types of ligament repairs are these devices specifically designed for, and how do they differ in their components?

  The FairFix AM and FairFix PSP Adjustable Buttons are designed for ligament reconstruction, specifically for anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) repairs. The FairFix AM includes a metal button, a nonabsorbable adjustable suture loop, a pulling suture, and a flipping suture, while the FairFix PSP is an extracortical fixation device with a nonabsorbable adjustable suture loop only. Both feature adjustable suture loops and metal components to secure graft placement during surgery, ensuring stable fixation at the bone-tunnel interface.

• Are these devices intended for reuse or single-use, and how are they packaged for surgical use?

  These devices are intended for single-use only. They are pre-assembled on an implant card, which simplifies handling and streamlines graft connection during surgery, reducing preparation time in the operating room.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed the submission?

  The FairFix AM and FairFix PSP Adjustable Buttons received FDA 510(k) clearance under Special Review (K221389). The submission was reviewed by the Orthopedic (OR) Advisory Committee, and the device was classified under the product code MBI (Musculoskeletal Biologics and Materials).

• How do the adjustable suture loops in these devices contribute to the surgical procedure?

  The adjustable suture loops in both the FairFix AM and FairFix PSP allow surgeons to fine-tune graft tension and positioning during ligament reconstruction. This adjustability ensures stable fixation at the bone-tunnel interface, helping to secure the graft securely in place while accommodating variations in anatomy and surgical technique.