K181280 is an FDA 510(k) clearance for the Patello-Femoral Wave (Kahuna) Arthroplasty System. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.3540.
| 510(k) Number | K181280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | KRR - Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3540 |