Atlas FDA

KRO

87 FDA 510(k) clearances · Product code

88 daysmedian time to decision
257 days90th percentile
87clearances measured

FDA profile

Official device name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3510
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 770 · 2022: 892 · 2023: 746 · 2024: 855 · 2025: 926 · 2026: 509
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (K261898)Howmedica Osteonics Corp. dba Stryker Orthopaedics2026-08-06
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (K252898)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-12-15
Stem Extension Line (USTAR II System) (K252303)United Orthopedic Corporation2025-08-22
Triathlon® Hinge Knee System (K251665)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-07-25
ATTUNE™ Revision Hinge Knee (K242871)Depuy Ireland UC2024-11-21
EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (K240043)Microport Orthopedics, Inc.2024-04-01
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
EVOLUTION® Hinge Knee System (K230563)Microport Orthopedics, Inc.2023-09-27
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416)Stryker2023-05-19
Modular Rotating Hinge Knee Systems and Compatible Components (K223069)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-04-21
Triathlon® Hinge Knee System (K223528)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-20
LINK Endo-Model EVO Knee System (K220628)Waldemar Link GmbH & Co. KG2022-05-03
ELEOS Limb Salvage System (K211677)Onkos Surgical2021-07-28
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE (K211768)Waldemar Link GmbH & Co. KG2021-06-30
GMK Revision & Hinge Extension - TiNbN Coating (K210010)Medacta International S.A.2021-03-02
Zimmer Segmental System (K192798)Zimmer, Inc.2020-12-10
Instruments for LINK MEGASYSTEM-C Family (K190181)LinkBio Corp.2019-10-25
Attune Revision LPS Inserts (K191779)Depuy(Ireland)2019-10-08
USTAR II System (K190100)United Orthopedic Corporation2019-09-23
GMK Hinge, GMK Revision (K172347)Medacta International S.A.2017-11-01
GMK Revision Femoral Distal Augmentation (K163311)Medacta International S.A.2016-12-21
ELEOS Limb Salvage System (K161520)Onkos Surgical, Inc.2016-10-28
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating (K152431)Waldemar Link GmbH & Co. KG2016-05-09
LINK® MEGASYSTEM-C® (K151008)Waldemar Link GmbH & Co. KG2015-08-26
Smith and Nephew Legion Hinge Knee System (K151118)Smith & Nephew2015-07-28
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT (K140900)Stanmore Worldwide Implants , Ltd.2015-02-12
Zimmer Segmental System XT Components (K150028)Zimmer, Inc.2015-02-06
The LINK® Endo-Model® Knee System (K143179)Waldemar Link GmbH & Co. KG2015-01-30
PATIENT SPECIFIC DISTAL FEMORAL (K140898)Stanmore Implants Worldwide , Ltd.2015-01-20
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE (K140509)Biomet Manufacturing, LLC2014-05-28
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (K133152)Stanmore Implants Worldwide , Ltd.2014-01-22
MAK OSS FEMORAL KNEE COMPONENTS (K131393)Biomet Orthopedics Corp.2013-10-24
GMK HINGE (K130299)Medacta International2013-08-15
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE (K122015)Howmedica Osteonics Corp.2013-02-22
METS MODULAR DISTAL FEMUR (K121029)Stanmore Implants Worldwide , Ltd.2012-09-19
METS SMILES TOTAL KNEE REPLACEMENT (K120992)Stanmore Implants Worldwide , Ltd.2012-09-05
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN (K110940)Zimmer, Inc.2011-07-01
JTS EXTENDEABLE IMPLANT (K092138)Stanmore Implants Worldwide , Ltd.2011-03-22
ENDURO KNEE SYSTEM (K101815)Aesculap Implant Systems2010-12-20
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 (K091453)DePuy Orthopaedics, Inc.2009-08-12
MAK OSS KNEE FEMORAL COMPONENTS (K083779)Biomet Manufacturing Corp2009-04-03
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES (K083827)Biomet Manufacturing Corp2009-02-13
LEGION HINGE KNEE SYSTEM (K081111)Smith & Nephew, Inc.2008-07-23
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER (K080330)Biomet, Inc.2008-06-11
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR (K072367)Wrightmedicaltechnologyinc2008-01-09
ZIMMER SEGMENTAL SYSTEM (K070978)Zimmer, Inc.2007-07-03
DEPUY LPS PROXIMAL TIBIAL COMPONENT (K062301)DePuy Orthopaedics, Inc.2006-10-13
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS (K060360)Howmedica Osteonics Corp.2006-03-15
OSS-BODIES PROXIMAL TIBIAL SLEEVE (K060131)Biomet Manufacturing Corp2006-02-15
ORTHOPEDIC SALVAGE SYSTEM- OSS (K052685)Biomet, Inc.2005-10-27
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS (K051479)Biomet Manufacturing, Inc.2005-08-10
AVL HINGE KNEE SYSTEM (K051570)Biomet, Inc.2005-08-05
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM (K041352)Biomet, Inc.2004-07-30
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS (K040749)Howmedica Osteonics Corp.2004-06-17
COMPRESS DISTAL FEMORAL REPLACEMENT (K031804)Biomet, Inc.2003-12-18
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT (K031480)Howmedica Osteonics Corp.2003-07-31
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE (K023667)Plus Orthopedics2002-12-24
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) (K023087)Howmedica Osteonics Corp.2002-12-16
REPIPHYSIS LIMB SALVAGE SYSTEM (K021489)Wrightmedicaltechnologyinc2002-12-04
RT-PLUS PE INSERT CLAMP (K021714)Plus Orthopedics2002-06-21
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM (K021260)Biomet, Inc.2002-06-05
EXPANDABLE KNEE (K020381)Biomet Orthopedics, Inc.2002-05-06
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE (K013385)Zimmer, Inc.2002-01-09
RT-PLUS KNEE ADDITIONAL COMPONENTS (K013340)Plus Orthopedics2001-12-20
GUARDIAN LIMB SALVAGE SYSTEM (K013035)Wrightmedicaltechnologyinc2001-12-07
MOST OPTIONS SYSTEM (K013031)Sulzer Orthopedics, Inc.2001-12-07
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (K011810)Depuy, Inc.2001-09-07
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS (K003504)Plus Orthopedics2001-05-11
AVL HINGE KNEE SYSTEM (K010774)Biomet, Inc.2001-04-13
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE (K002552)Howmedica Osteonics Corp.2000-11-13
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT (K001957)Howmedica Osteonics Corp.2000-07-25
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS (K001548)Howmedica Osteonics Corp.2000-06-07
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE (K994207)Howmedica Osteonics Corp.2000-03-13
HINGED KNEE (K982160)Encore Orthopedics, Inc.1999-03-17
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS (K972401)Howmedica Corp.1998-07-13
FINN KNEE SYSTEM (K945028)Biomet, Inc.1996-02-14
FINN KNEE PROSTHESIS (K910877)Biomet, Inc.1991-07-26
DCW MODULAR DISTAL FEMORAL SYSTEM (K910596)Dow Corning Wright1991-05-29
S-ROM/NOILES MARK 3 (K896048)Joint Medical Products Corp.1990-03-14
KINEMATIC II KNEE SYSTEM (K823420)Howmedica Corp.1983-02-07
NATURALYTE BICARBONATE DIALYSATE 4400 (K823115)Erika, Inc.1982-12-03
BARD ENDO LINK INTRACONDYLAR ROTATING (K821476)C.R. Bard, Inc.1982-06-23
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH. (K821340)Intermedics Orthopedics1982-05-27
MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS (K820995)Ludek Optics, Inc.1982-05-25
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH (K811105)Allo Pro Corp.1981-07-27
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL (K810520)Zimmer, Inc.1981-03-26
KNEE SYSTEM, QUADRAXIAL CONSTRAINED (K781971)Hexcel Medical1979-04-04

Track KRO automatically

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