Prelude PF Patellae
FDA 510(k) K143543 · Biomet, Inc.
510(k) numberK143543
Submission
- Device name
- Prelude PF Patellae
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- December 15, 2014
- Decision date
- January 30, 2015
- 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 |
| 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 |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | 05/19/2026SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was Prelude PF Patellae cleared by the FDA?
Prelude PF Patellae (K143543) received a 510(k) decision of Substantially Equivalent on January 30, 2015, 46 days after the submission was received.
What is the product code of K143543?
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.