Product code HRY— Orthopedic
ADVANCE UNICONDYLAR KNEE SYSTEM
- Classification name
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Regulation
- 21 CFR 888.3530
- Advisory panel
- Orthopedic
- Total cleared
- 91
- First cleared
- Most recent
Market context for product code HRY
FDA has cleared devices under product code HRY between 1976 and 2020, filed by 44 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2019
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
Top applicants under product code HRY
Adverse events under product code HRY
product code HRY- Injury
- 1,551
- Malfunction
- 2,753
- Total
- 4,304
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HRY
- K193549 — SIGMA High Performance (HP) Partial Knee System
- K190633 — NanoOrtho NanoKnee® System
- K152631 — MPO Total Knee Systems MR Labeling
- K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM
- K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
- K131167 — UNIVATION
- K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
- K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES
- K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM
- K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
- K081293 — UNIVATION UNICONDYLAR KNEE SYSTEM
- K072704 — UNICOMPARTMENTAL KNEE
- K071881 — TRIATHLON PKR SYSTEM
- K070267 — DEPUY GCK TIBIAL COMPONENTS
- K063515 — TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
- K061681 — REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT
- K060412 — ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
- K053299 — REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT
- K051721 — GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
- K050764 — UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
- K042093 — VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
- K040889 — EXACTECH OPTETRAK UNICONDYLAR KNEE
- K040268 — DEPUY PRESERVATION UNICONDYLAR TIBIA
- K033351 — GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
- K033810 — NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
- K032052 — UC-PLUS SOLUTION UNICONDYLAR KNEE
- K030446 — REPICCI LOCKED KEEL TIBIAL BEARING
- K030193 — ADVANCE LESS CONFORMING TIBIAL COMPONENT
- K022437 — UNI KNEE
- K021621 — FIXED BEARING UNI COMPONENT
- K020741 — UNICONDYLAR KNEE
- K012800 — SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM
- K014171 — ADVANCE UNICONDYLAR KNEE SYSTEM
- K020264 — REPICCI II UNICONDYLAR KNEE SYSTEM
- K012762 — MJS POSTERIOR STABILIZED KNEE SYSTEM
- K012591 — ADVANCE UNICONDYLAR KNEE SYSTEM
- K011138 — OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
- K011509 — BARRETT UNICONDYLAR TIBIAL BEARING
- K011795 — WORLAND UNICONDYLAR TIBIAL BEARING
- K010810 — DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
- K001451 — MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
- K983657 — OSTEONICS SERIES 7000 AD TIBIAL TRAY
- K000172 — DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
- K982859 — UC-PLUS SOLUTION UNICONDYLAR KNEE SYSTEM
- K980665 — REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS
- K974434 — OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS
- K971938 — REPICCI II UNICONDYLAR KNEE
- K954481 — P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
- K961900 — TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
- K960617 — ADVANCE TIBIAL COMPONENT
- K955778 — NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM
- K944538 — GAS PLASMA STERILIZATION
- K940389 — S.T.E.P. UNI-KNEE
- K933935 — CKS POROUS COATED FEMORAL COMPONENT
- K923011 — OSTEONICS UNIX UNICOMPARTMENTAL
- K910968 — P.F.C. UNICONDYLAR KNEE SYSTEM
- K911373 — OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
- K902538 — WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
- K890044 — BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
- K883969 — UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
- K884837 — KINEMAX TIBIAL WEDGE
- K882241 — KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
- K873601 — AGC UNICOMPARTMENTAL KNEE PROSTHESIS
- K864070 — WHITESIDE ORTHOLOC (TM)
- K862125 — ARIZONA CONDYLAR TIBIAL PLATEAU
- K860133 — MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
- K842367 — HOWMEDICA KINEMATIC II TIBIAL WEDGE
- K834298 — UNICONDYLAR FIBER METAL KNEE
- K831143 — P.C.A. UNICOMPARTMENTAL KNEE PROSTHES
- K821341 — IOI METAL BACKED TIBIAL COMPONENT
- K820002 — BARD CONTOUR LINK S.K.I. KNEE SYS
- K820030 — HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE
- K812012 — TOWNLEY UNICONDYLAR KNEE
- K810060 — P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH
- K810540 — KNEE PROSTHESIS
- K810616 — MILLER MULTI-RADIUS TOTAL KNEE
- K810230 — CONDYLAR KNEE W/METAL ENCAPSULATED TIB
- K802446 — RANAWAT ESF TOTAL CONDYLAR KNEE
- K792619 — RMC KNEE METAL SHOE TIBIAL COMPONENTS
- K792325 — LIVERPOOL KNEE PROSTHESIS
- K790762 — PLATFORM TCCK TOTAL KNEE
- K790348 — ANAMETRIC TIBIAL COMPONENT METAL TRAY
- K790349 — TOTAL CONDYLAR KNEE PROSTHESIS
- K790350 — POSTERIOR CRUCIATE CONDYLAR TIBIAL
- K781608 — CENTRAL PEG TIBIAL COMPONENT
- K780299 — TOTAL KNEE SYSTEM
- K761278 — TOTAL TIBIAL KNEE
- K760842 — GEOMEDIC ANAMETRIC TOTAL KNEE
- K760744 — TAVERNETTI-TENNANT
- K760334 — PROSTEHSIS, TOTAL KNEE REPLACEMENT
- K760245 — PROSTHESIS, RICHARDS MOD II KNEE
Data sourced from openFDA. This site is unofficial and independent of the FDA.