HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class II
FDA Device Classification
Classification Details
- Product Code
- HRY
- Device Class
- Class II
- Regulation Number
- 888.3530
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K193549 | depuy ireland uc | SIGMA High Performance (HP) Partial Knee System | April 16, 2020 |
| K190633 | nanoortho | NanoOrtho NanoKnee® System | December 20, 2019 |
| K152631 | microport orthopedics | MPO Total Knee Systems MR Labeling | March 23, 2016 |
| K150410 | mako surgical corporation | RESTORIS POROUS PARTIAL KNEE SYSTEM | March 20, 2015 |
| K133940 | biomet uk | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | March 28, 2014 |
| K131167 | aesculap implant systems | UNIVATION | October 17, 2013 |
| K122277 | biomet manufacturing | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) | October 22, 2012 |
| K110415 | materialise | SIGNATURE PLANNER / SIGNATURE GUIDES | May 16, 2011 |
| K100973 | wrightmedicaltechnologyinc | EVOLUTION UNICONDYLAR KNEE SYSTEM | August 10, 2010 |
| K082567 | howmedica osteonics | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | October 3, 2008 |
| K081293 | aesculap implant systems | UNIVATION UNICONDYLAR KNEE SYSTEM | September 22, 2008 |
| K072704 | valpo orthopedic technology | UNICOMPARTMENTAL KNEE | February 19, 2008 |
| K071881 | howmedica osteonics | TRIATHLON PKR SYSTEM | October 9, 2007 |
| K070267 | depuy orthopaedics | DEPUY GCK TIBIAL COMPONENTS | August 17, 2007 |
| K063515 | biomet manufacturing | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDY | February 2, 2007 |
| K061681 | biomet manufacturing | REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT | October 19, 2006 |
| K060412 | australian surgical design and manufacture | ACTIVE UNICOMPARTMENTAL KNEE SYSTEM | May 17, 2006 |
| K053299 | biomet manufacturing | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT | January 5, 2006 |
| K051721 | global orthopaedic technology, usa | GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM | October 26, 2005 |
| K050764 | corin usa | UNIGLIDE UNICONDYLAR KNEE PROSTHESIS | August 24, 2005 |