Atlas FDA

KRR

27 FDA 510(k) clearances · Product code

89 daysmedian time to decision
258 days90th percentile
27clearances measured

FDA profile

Official device name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3540
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2016: 14 · 2017: 15 · 2018: 14 · 2019: 16 · 2024: 25 · 2025: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Overture Orthopaedics Patellofemoral System (K231253)Overture Resurfacing, Inc.2023-07-07
Episealer Patellofemoral System (K221048)Episurf Medical, Inc.2022-12-23
Avon Patello-femoral Joint Prosthesis (K211303)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2021-06-04
MOTO PFJ System (K200122)Medacta International S.A.2020-04-20
Patello-Femoral Wave (Kahuna) Arthroplasty System (K181280)Arthrosurface, Inc.2018-06-14
Arthrex iBalance BiCompartmental Arthroplasty System (K160461)Arthrex, Inc.2016-04-12
Prelude PF Patellae (K143543)Biomet, Inc.2015-01-30
PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, (K123907)Biomet Manufacturing Corp2013-09-03
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT (K111970)Tornier2012-02-23
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II (K082088)Mako Surgical Corp.2008-10-22
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM (K080029)Mako Surgical Corp.2008-05-16
ACCIN PATELLOFEMORAL SYSTEM (K073120)Accelerated Innovation, LLC2008-02-29
HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM (K071413)Arthrosurface, Inc.2007-11-09
ZIMMER PATELLOFEMORAL JOINT PROSTHESIS (K070695)Zimmer, Inc.2007-06-07
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS (K060127)Arthrosurface, Inc.2006-03-16
RBK PATELLA FEMORAL KNEE (K050473)Global Orthopaedic Technology, USA, Inc.2005-11-14
AVON PATELLO-FEMORAL JOINT PROSTHESIS (K051948)Howmedica Osteonics Corp.2005-10-21
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT (K051086)Smith & Nephew, Inc.2005-05-31
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT (K041160)Howmedica Osteonics Corp.2004-05-27
KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (K013982)Kinamed, Inc.2002-05-21
AVON PATELLAR COMPONENT (K020841)Howmedica Osteonics Corp.2002-04-11
AVON PATELLO-FEMORAL JOINT PROSTHESIS (K010100)Howmedica Osteonics Corp.2001-04-06
NATURAL-KNEE II PATELLOFEMORAL JOINT PROSTHESIS (K002356)Sulzer Orthopedics, Inc.2000-10-30
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT (K001374)Biomet Manufacturing, Inc.2000-07-27
PATIENT MATCHED TITANIUM ALLOY TROCHLEA (K001350)Biomet, Inc.2000-07-26
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED (K000827)Walter Abendschein, M.D.2000-06-23
PATELLOFEMORAL JOINT PROSTHESIS (K962190)Intermedics Orthopedics1996-10-28

Track KRR automatically

Every clearance here is in the API, with alerts when new ones post.