Mako Surgical Corp. Patellofemoral Knee Implant System II
FDA 510(k) K082088 · Mako Surgical Corp.
510(k) numberK082088
Submission
- Device name
- Mako Surgical Corp. Patellofemoral Knee Implant System II
- Applicant
- Mako Surgical Corp.
Fort Lauderdale, FL, US - Received
- July 24, 2008
- Decision date
- October 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty SystemKRR · Special | Arthrosurface, Inc. | 06/14/2018SE |
| 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 |
| K080029 | Mako Surgical Corp. Patellofemoral Knee Implant SystemKRR · Traditional | Mako Surgical Corp. | 05/16/2008SE |
More from Mako Surgical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K260222 | Mako Total Knee ApplicationOLO · Special | 02/25/2026SE |
| K250608 | Mako Total Knee Application (3.0); Hybrid Tip PointerOLO · Traditional | 04/25/2025SE |
| K243751 | Mako Total Hip Application 5.0OLO · Traditional | 03/05/2025SE |
| K242373 | Mako Shoulder Application (1.0)OLO · Traditional | 11/07/2024SE |
| K241011 | Mako Total Knee ApplicationOLO · Traditional | 06/11/2024SE |
| K220930 | Restoris Multi-Compartmental Knee SystemHSX · Traditional | 06/02/2022SE |
| K220459 | Mako Total Knee ApplicationOLO · Traditional | 04/15/2022SE |
| K193515 | Mako Total Knee ApplicationOLO · Traditional | 07/14/2020SE |
| K193128 | Mako Total Hip ApplicationOLO · Traditional | 02/02/2020SE |
| K191998 | Mako Total Hip Application, Mako Total Knee ApplicationOLO · Traditional | 09/24/2019SE |
Questions and answers
When was Mako Surgical Corp. Patellofemoral Knee Implant System II cleared by the FDA?
Mako Surgical Corp. Patellofemoral Knee Implant System II (K082088) received a 510(k) decision of Substantially Equivalent on October 22, 2008, 90 days after the submission was received.
What is the product code of K082088?
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.