HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Class II
FDA product code HRY covers "Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3530. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |