Product code KRR
- Device name
- Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3540
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231253 | Overture Orthopaedics Patellofemoral System | Overture Resurfacing, Inc. | 2023-07-07 |
| K221048 | Episealer Patellofemoral System | Episurf Medical, Inc. | 2022-12-23 |
| K211303 | Avon Patello-femoral Joint Prosthesis | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-06-04 |
| K200122 | MOTO PFJ System | Medacta International S.A. | 2020-04-20 |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Arthrosurface, Inc. | 2018-06-14 |
| K160461 | Arthrex iBalance BiCompartmental Arthroplasty System | Arthrex, Inc. | 2016-04-12 |
| K143543 | Prelude PF Patellae | Biomet, Inc. | 2015-01-30 |
| K123907 | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, | Biomet Manufacturing Corp | 2013-09-03 |
| K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | Tornier | 2012-02-23 |
| K082088 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II | Mako Surgical Corp. | 2008-10-22 |
| K080029 | MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM | Mako Surgical Corp. | 2008-05-16 |
| K073120 | ACCIN PATELLOFEMORAL SYSTEM | Accelerated Innovation, LLC | 2008-02-29 |
| K071413 | HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM | Arthrosurface, Inc. | 2007-11-09 |
| K070695 | ZIMMER PATELLOFEMORAL JOINT PROSTHESIS | Zimmer, Inc. | 2007-06-07 |
| K060127 | HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS | Arthrosurface, Inc. | 2006-03-16 |
| K050473 | RBK PATELLA FEMORAL KNEE | Global Orthopaedic Technology, USA, Inc. | 2005-11-14 |
| K051948 | AVON PATELLO-FEMORAL JOINT PROSTHESIS | Howmedica Osteonics Corp. | 2005-10-21 |
| K051086 | SMITH & NEPHEW PATELLO-FEMORAL IMPLANT | Smith & Nephew, Inc. | 2005-05-31 |
| K041160 | AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT | Howmedica Osteonics Corp. | 2004-05-27 |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | Kinamed, Inc. | 2002-05-21 |
| K020841 | AVON PATELLAR COMPONENT | Howmedica Osteonics Corp. | 2002-04-11 |
| K010100 | AVON PATELLO-FEMORAL JOINT PROSTHESIS | Howmedica Osteonics Corp. | 2001-04-06 |
| K002356 | NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS | Sulzer Orthopedics, Inc. | 2000-10-30 |
| K001374 | PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT | Biomet Manufacturing, Inc. | 2000-07-27 |
| K001350 | PATIENT MATCHED TITANIUM ALLOY TROCHLEA | Biomet, Inc. | 2000-07-26 |
| K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | Walter Abendschein, M.D. | 2000-06-23 |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Intermedics Orthopedics | 1996-10-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00888867106697 | Arthrex® | ARTHREX, INC. | 2017-02-15 |
| 00848486016401 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016739 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016715 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016708 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016692 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016685 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016661 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016654 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016647 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016630 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016616 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016609 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016593 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016586 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016562 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016555 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016548 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016531 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016517 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016500 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016494 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016487 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016463 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016456 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016449 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016432 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 00848486016418 | Mako | MAKO SURGICAL CORP. | 2015-11-04 |
| 03596010544193 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |
| 03596010544209 | JOURNEY | Smith & Nephew, Inc. | 2015-08-30 |