Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper

These are artificial knee replacement components, including patellar (kneecap) components and a hinge knee bumper, intended for use in primary or revision knee arthroplasty (joint replacement surgery). They are used to treat painful knee conditions including degenerative arthritis, rheumatoid arthritis, and post-traumatic arthritis, as well as knee instability and deformity.

The subject devices are identical in design, materials, and operational principles to their predicate devices. The only difference is the packaging configuration: predicate devices use inner and outer blisters of Barex Modified Acrylonitrile copolymer with alternating vacuum and nitrogen purging, while the subject devices use an impermeable foil pouch in a PETG (polyethylene terephthalate glycol) blister sealed with a Tyvek lid, followed by vacuum and nitrogen purging.

Testing per ASTM F2977 (small punch), ASTM F2102 (oxidation index), ISO 11607-1 and 11607-2, ASTM F88/F88M, ASTM F2096, ASTM F1980, AAMI ST72 (endotoxin), and ISO 10993-5 (cytotoxicity).

The devices are substantially equivalent because they have identical intended use, indications for use, design, materials, and operational principles as their predicates. The packaging change was validated through non-clinical testing demonstrating that material properties and shelf-life (five years) are preserved, and biocompatibility testing confirmed no adverse effects from the new packaging materials.