Patello-Femoral Wave (Kahuna) Arthroplasty System
FDA 510(k) K181280 · Arthrosurface, Inc.
510(k) numberK181280
Submission
- Device name
- Patello-Femoral Wave (Kahuna) Arthroplasty System
- Applicant
- Arthrosurface, Inc.
Franklin, MA, US - Received
- May 15, 2018
- Decision date
- June 14, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRR – Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3540
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KRR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231253 | Overture Orthopaedics Patellofemoral SystemKRR · Traditional | Overture Resurfacing, Inc. | 07/07/2023SE |
| K221048 | Episealer Patellofemoral SystemKRR · Traditional | Episurf Medical, Inc. | 12/23/2022SE |
| K211303 | Avon Patello-femoral Joint ProsthesisKRR · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 06/04/2021SE |
| K200122 | MOTO PFJ SystemKRR · Traditional | Medacta International S.A. | 04/20/2020SE |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty SystemKRR · Traditional | Arthrex, Inc. | 04/12/2016SE |
| K143543 | Prelude PF PatellaeKRR · Traditional | Biomet, Inc. | 01/30/2015SE |
| K123907 | Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…KRR · Traditional | Biomet Manufacturing Corp | 09/03/2013SE |
| K111970 | Kneetec Pfj&Hls Kneetec Patellar ComponentKRR · Traditional | Tornier | 02/23/2012SE |
| K082088 | Mako Surgical Corp. Patellofemoral Knee Implant System IIKRR · Traditional | Mako Surgical Corp. | 10/22/2008SE |
| K080029 | Mako Surgical Corp. Patellofemoral Knee Implant SystemKRR · Traditional | Mako Surgical Corp. | 05/16/2008SE |
More from Mako Surgical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty SystemPHX · Traditional | 06/24/2021SE |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty SystemJWJ · Traditional | 10/15/2020SE |
| K190261 | BOSS Toe Fixation SystemKWD · Traditional | 08/14/2019SE |
| K173964 | OVOMotion Shoulder Arthroplasty SystemHSD · Traditional | 04/18/2018SE |
| K172383 | Arthrosurface Bone ScrewsHWC · Traditional | 12/22/2017SE |
| K170440 | KISSloc Suture SystemHTN · Traditional | 05/03/2017SE |
| K170350 | ToeMATE® Hammertoe Correction SystemHWC · Special | 03/03/2017SE |
| K162391 | AlignMATE Lapidus Arthrodesis SystemHRS · Special | 02/21/2017SE |
| K161539 | Arthrosurface Bone ScrewsHWC · Special | 06/30/2016SE |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemKWD · Special | 04/11/2016SE |
Questions and answers
When was Patello-Femoral Wave (Kahuna) Arthroplasty System cleared by the FDA?
Patello-Femoral Wave (Kahuna) Arthroplasty System (K181280) received a 510(k) decision of Substantially Equivalent on June 14, 2018, 30 days after the submission was received.
What is the product code of K181280?
The FDA product code is KRR – Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3540.