Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
The partial semi-constrained cemented polymer/metal/polymer knee patellofemorotibial prosthesis is an orthopedic implant intended to replace the medial condyle and patellofemoral compartment of the distal femur using a single device, used with a unicompartmental tibial base and insert and a resurfacing patella, and fixed with bone cement. It is classified as FDA Class 2 under regulation 888.3560 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag. Product code NPJ is not eligible for third-party review.
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Basic Information
- Product Code
- NPJ
- Device Class
- FDA class 2
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150307 | RESTORIS Multicompartmental Knee System | Mar 10, 2015 | Substantially Equivalent | Mako Surgical Corp. |
| K133039 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | Dec 10, 2013 | Substantially Equivalent | Mako Surgical Corporation |
| K093513 | IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM | Dec 16, 2009 | Substantially Equivalent | Conformis, Inc. |
| K093056 | SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM | Dec 15, 2009 | Substantially Equivalent | Smith & Nephew, Inc. |
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM | Jun 17, 2009 | Substantially Equivalent | Mako Surgical Corporation |
| K070849 | DEPUY GCK FEMORAL AND TIBIAL COMPONENTS | Jun 26, 2007 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K061648 | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) | Sep 11, 2006 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K061569 | SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS | Jul 06, 2006 | Substantially Equivalent | Smith & Nephew, Inc. |
| K053488 | CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM | Mar 09, 2006 | Substantially Equivalent | Conformis, Inc. |
| K052917 | STRYKER COMPARTMENTAL KNEE SYSTEM | Dec 27, 2005 | Substantially Equivalent | Howmedica Osteonics Corp. |
| K052265 | SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL | Dec 27, 2005 | Substantially Equivalent | Smith & Nephew, Inc. |
| K042896 | SMITH & NEPHEW HYBRID KNEE FEMORAL | Jan 12, 2005 | Substantially Equivalent | Smith & Nephew, Inc. |
FEI Numbers
This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.