Overture Orthopaedics Patellofemoral System
FDA 510(k) K231253 · Overture Resurfacing, Inc.
510(k) numberK231253
Submission
- Device name
- Overture Orthopaedics Patellofemoral System
- Applicant
- Overture Resurfacing, Inc.
New York, NY, US - Received
- May 1, 2023
- Decision date
- July 7, 2023
- 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 |
|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K221292 | Uni Knee Resurfacing SystemHSX · Traditional | 03/10/2023SE |
Questions and answers
When was Overture Orthopaedics Patellofemoral System cleared by the FDA?
Overture Orthopaedics Patellofemoral System (K231253) received a 510(k) decision of Substantially Equivalent on July 7, 2023, 67 days after the submission was received.
What is the product code of K231253?
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.