KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Class II
FDA product code KRR covers "Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3540. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRR
- Device Class
- Class II
- Regulation Number
- 888.3540
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231253 | overture resurfacing | Overture Orthopaedics Patellofemoral System | July 7, 2023 |
| K221048 | episurf medical | Episealer Patellofemoral System | December 23, 2022 |
| K211303 | howmedica osteonics corp., dba stryker orthopaedics | Avon Patello-femoral Joint Prosthesis | June 4, 2021 |
| K200122 | medacta international | MOTO PFJ System | April 20, 2020 |
| K181280 | arthrosurface | Patello-Femoral Wave (Kahuna) Arthroplasty System | June 14, 2018 |
| K160461 | arthrex | Arthrex iBalance BiCompartmental Arthroplasty System | April 12, 2016 |
| K143543 | biomet | Prelude PF Patellae | January 30, 2015 |
| K123907 | biomet manufacturing | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST | September 3, 2013 |
| K111970 | tornier | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | February 23, 2012 |
| K082088 | mako surgical | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | October 22, 2008 |
| K080029 | mako surgical | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | May 16, 2008 |
| K073120 | accelerated innovation | ACCIN PATELLOFEMORAL SYSTEM | February 29, 2008 |
| K071413 | arthrosurface | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | November 9, 2007 |
| K070695 | zimmer | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS | June 7, 2007 |
| K060127 | arthrosurface | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | March 16, 2006 |
| K050473 | global orthopaedic technology, usa | RBK PATELLA FEMORAL KNEE | November 14, 2005 |
| K051948 | howmedica osteonics | AVON PATELLO-FEMORAL JOINT PROSTHESIS | October 21, 2005 |
| K051086 | smith and nephew | SMITH & NEPHEW PATELLO-FEMORAL IMPLANT | May 31, 2005 |
| K041160 | howmedica osteonics | AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT | May 27, 2004 |
| K013982 | kinamed | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | May 21, 2002 |