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510(k) K211303

Device
Avon Patello-femoral Joint Prosthesis
Applicant
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
510(k) number
K211303
Product code
KRR  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-04
Date received
2021-04-29
Regulation
888.3540
Classification name
Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Shraddha More
Address
325 Corporate Dr. Mahwah NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KRR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.2023-07-07
K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.2022-12-23
K200122MOTO PFJ SystemMedacta International S.A.2020-04-20
K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.2018-06-14
K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, Inc.2016-04-12
K143543Prelude PF PatellaeBiomet, Inc.2015-01-30
K123907PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,Biomet Manufacturing Corp2013-09-03
K111970KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENTTornier2012-02-23
K082088MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM IIMako Surgical Corp.2008-10-22
K080029MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEMMako Surgical Corp.2008-05-16
K073120ACCIN PATELLOFEMORAL SYSTEMAccelerated Innovation, LLC2008-02-29
K071413HEMICAP PATELLO-FEMORAL RESURFACING SYSTEMArthrosurface, Inc.2007-11-09
K070695ZIMMER PATELLOFEMORAL JOINT PROSTHESISZimmer, Inc.2007-06-07
K060127HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESISArthrosurface, Inc.2006-03-16
K050473RBK PATELLA FEMORAL KNEEGlobal Orthopaedic Technology, USA, Inc.2005-11-14

Legacy Summary#

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FDA Review#

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