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510(k) K123907

Device
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
Applicant
BIOMET MANUFACTURING CORP.
510(k) number
K123907
Product code
KRR  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-03
Date received
2012-12-19
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
ELIZABETH WRAY
Address
56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581

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
K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics2021-06-04
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
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#

summary

FDA Review#

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