NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II
FDA product code NPJ covers "Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3560. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NPJ
- Device Class
- Class II
- Regulation Number
- 888.3560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150307 | mako surgical | RESTORIS Multicompartmental Knee System | March 10, 2015 |
| K133039 | mako surgical corporation | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | December 10, 2013 |
| K093513 | conformis | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | December 16, 2009 |
| K093056 | smith and nephew | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | December 15, 2009 |
| K090763 | mako surgical corporation | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | June 17, 2009 |
| K070849 | depuy orthopaedics | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | June 26, 2007 |
| K061648 | depuy orthopaedics | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) | September 11, 2006 |
| K061569 | smith and nephew | SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS | July 6, 2006 |
| K053488 | conformis | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | March 9, 2006 |
| K052917 | howmedica osteonics | STRYKER COMPARTMENTAL KNEE SYSTEM | December 27, 2005 |
| K052265 | smith and nephew | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL | December 27, 2005 |
| K042896 | smith and nephew | SMITH & NEPHEW HYBRID KNEE FEMORAL | January 12, 2005 |