MOTO PFJ System
FDA 510(k) K200122 · Medacta International S.A.
510(k) numberK200122
Submission
- Device name
- MOTO PFJ System
- Applicant
- Medacta International S.A.
Castel San Pietro (Ch), CH - Received
- January 21, 2020
- Decision date
- April 20, 2020
- 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 |
| 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 |
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| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | 02/26/2026SE |
| K250644 | MSS - Monobloc stemPHX · Traditional | 02/03/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | 01/28/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | 01/09/2026SE |
| K242603 | MyPAO SA guidesPBF · Traditional | 11/19/2025SE |
| K250338 | MSS - Humeral reverse liners extensionPHX · Traditional | 10/31/2025SE |
| K250450 | Coated hip implantsLZO · Traditional | 09/19/2025SE |
Questions and answers
When was MOTO PFJ System cleared by the FDA?
MOTO PFJ System (K200122) received a 510(k) decision of Substantially Equivalent on April 20, 2020, 90 days after the submission was received.
What is the product code of K200122?
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.