510(k) K181280

Patello-Femoral Wave (Kahuna) Arthroplasty System by Arthrosurface, Inc. — Product Code KRR

K181280 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "Patello-Femoral Wave (Kahuna) Arthroplasty System". The FDA issued a decision of Substantially Equivalent on June 14, 2018. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.