Cleared Special

Patello-Femoral Wave (Kahuna) Arthroplasty System

K181280 · Arthrosurface, Inc. · Orthopedic

Jun 2018

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K181280 is an FDA 510(k) clearance for the Patello-Femoral Wave (Kahuna) Arthroplasty System, a Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRR), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on June 14, 2018, 30 days after receiving the submission on May 15, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3540.

Submission Details

510(k) Number	K181280 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2018
Decision Date	June 14, 2018
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KRR — Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3540