FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K032108 |
AESCULAP, INC. |
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) |
01/15/2004 |
K171365 |
Arthrex Inc. |
Arthrex Knee Systems |
11/07/2017 |
K152252 |
ARTHREX, INC. |
Arthrex iBalance TKA System |
11/16/2015 |
K141635 |
ARTHREX, INC. |
ARTHREX IBALANCE TKA SYSTEM |
09/03/2014 |
K153586 |
Arthrex, Inc. |
Arthrex iBalance TKA System |
02/19/2016 |
K041872 |
BIOMET MANUFACTURING CORP. |
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS |
09/08/2004 |
K083782 |
BIOMET MANUFACTURING CORP. |
REGENEREX PATELLA COMPONENTS |
04/03/2009 |
K060303 |
BIOMET MANUFACTURING CORP. |
VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS |
03/30/2006 |
K122160 |
BIOMET MANUFACTURING CORP. |
VANGUARD XP KNEE SYSTEM |
03/20/2013 |
K053505 |
BIOMET MANUFACTURING, INC. |
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS |
08/14/2006 |
K061433 |
BIOMET MANUFACTURING, INC. |
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE |
08/21/2006 |
K033489 |
BIOMET, INC. |
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN |
06/02/2004 |
K080361 |
BIOMET, INC. |
REGENEREX TIBIAL COMPONENTS |
04/21/2008 |
K140883 |
BIOMET, INC. |
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT |
07/30/2014 |
K050222 |
BIOMET, INC. |
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS |
08/16/2005 |
K141407 |
BIOMET, INC. |
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL |
10/27/2014 |
K132873 |
BIOMET, INC. |
VANGUARD XP KNEE SYSTEM |
12/11/2013 |
K153657 |
BIOMET, INC. |
Vanguard XP Knee System |
05/10/2016 |
K232426 |
Conformis Inc |
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts |
09/08/2023 |
K223316 |
Conformis Inc. |
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System |
07/21/2023 |
K102927 |
Consensus Orthopedics, Inc |
CONSENSUS KNEE SYSTEM |
01/26/2011 |
K110950 |
CONSENSUS ORTHOPEDICS, INC. |
CONSENSUS KNEE SYSTEM |
06/27/2011 |
K140881 |
DEPUY (IRELAND) |
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS |
02/13/2015 |
K212746 |
Depuy Ireland UC |
ATTUNE Revision Cones |
10/17/2022 |
K213781 |
DePuy Ireland UC |
ATTUNE« Porous Fixed Bearing Tibial Base with AFFIXIUMÖ 3DP |
01/18/2022 |
K202194 |
DePuy Ireland UC |
ATTUNE« Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUMÖ 3DP Technology |
11/25/2020 |
K230295 |
DePuy Ireland UC |
ATTUNE« Revision Cones |
03/10/2023 |
K071417 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES |
08/02/2007 |
K062654 |
DEPUY ORTHOPAEDICS, INC. |
DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS |
09/29/2006 |
K210308 |
Encore Medical, L.P. |
EMPOWR Porous Femur with HAnano SurfaceTM |
03/30/2021 |
K171991 |
Encore Medical, L.P. |
EMPOWR Porous Knee System |
10/04/2017 |
K212941 |
Encore Medical, L.P. dba DJO Surgical |
Porous Patella |
01/20/2022 |
K032905 |
ENCORE ORTHOPEDICS, INC. |
3DKNEE POROUS COATED FEMORAL COMPONENT |
07/06/2004 |
K153776 |
Exactech Inc |
Optetrak One Logic Femoral Components |
03/10/2016 |
K140302 |
EXACTECH, INC. |
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS |
07/30/2014 |
K181794 |
Exactech, Inc. |
Truliant Porous Femoral Components |
09/28/2018 |
K182346 |
Exactech, Inc. |
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws |
11/26/2018 |
K043374 |
HOWMEDICA OSTEONICS CORP |
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING |
02/16/2005 |
K033972 |
HOWMEDICA OSTEONICS CORP |
SCORPIO TOTAL KNEE SYSTEM |
04/12/2004 |
K033971 |
HOWMEDICA OSTEONICS CORP |
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
05/28/2004 |
K061521 |
HOWMEDICA OSTEONICS CORP |
TRIATHLON METAL BACKED PATELLA |
08/11/2006 |
K051380 |
HOWMEDICA OSTEONICS CORP |
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM |
08/30/2005 |
K172634 |
Howmedica Osteonics Corp aka Stryker Orthopaedics |
Triathlon« X3« UHMWPE Tibial Inserts and Patellar Components |
11/16/2017 |
K032163 |
HOWMEDICA OSTEONICS CORP. |
DURACON TOTAL KNEE SYSTEM |
09/12/2003 |
K032418 |
HOWMEDICA OSTEONICS CORP. |
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING |
09/11/2003 |
K070883 |
HOWMEDICA OSTEONICS CORP. |
DURACON X3 CS TIBIAL INSERT |
05/11/2007 |
K200782 |
Howmedica Osteonics Corp. |
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite |
05/13/2020 |
K190991 |
Howmedica Osteonics Corp. (aka Stryker Orthopaedics) |
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment |
08/15/2019 |
K031462 |
IMPLEX CORP. |
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS |
08/06/2003 |
K040487 |
IMPLEX CORP. |
TRABECULAR METAL KNEE SYSTEM AUGMENTS |
12/21/2004 |
K201084 |
LimaCorporate S.p.A. |
Physica system |
12/14/2020 |
K210554 |
Limacorporate S.p.A. |
Physica system |
04/06/2021 |
K140257 |
MATERIALISE N.V. |
SIGNATURE PLANNER, SIGNATURE GUIDES |
04/02/2014 |
K093533 |
MATERIALISE N.V. |
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 |
02/17/2010 |
K150680 |
MAXX ORTHOPEDICS, INC. |
Freedom Cementless Femoral Component |
06/26/2015 |
K221850 |
Medacta International S.A. |
GMK 3D Metal Tibial Tray |
08/23/2022 |
K223548 |
Medacta International S.A. |
GMK Sphere & GMK SpheriKA Cementless |
01/20/2023 |
K143366 |
MicroPort Orthopedics Inc. |
ADVANCE Porous Coated Spiked Tibial Base |
01/21/2015 |
K140735 |
MICROPORT ORTHOPEDICS INC. |
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS |
08/29/2014 |
K213817 |
MicroPort Orthopedics Inc. |
MPO Knee Instruments; MPO PROPHECY Knee Instruments |
01/05/2022 |
K170288 |
MicroPort Orthopedics, Inc. |
BIOFOAM« Additive Manufacturing (BIOFOAM« AM), ADVANCE« BIOFOAM« Tibial Base, EVOLUTION« BIOFOAM« Tibial Base, DYNASTY« BIOFOAM« Acetabular Shell |
06/15/2017 |
K152298 |
MICROPORT ORTHOPEDICS, INC. |
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base |
11/16/2015 |
K180317 |
MicroPort Orthopedics, Inc. |
EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System |
05/04/2018 |
K080842 |
OMNI LIFE SCIENCE, INC. |
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] |
05/23/2008 |
K220049 |
Optimotion Implants, LLC |
Optimotion Implants Porous Metal-Backed Patella |
03/14/2022 |
K191084 |
Optimotion Implants, LLC |
The Optimotion Blue Total Knee System |
04/07/2020 |
K051510 |
SIGNAL MEDICAL CORP. |
SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM |
03/22/2006 |
K203779 |
Signal Medical Corporation |
Symmetric Total Knee System |
06/10/2021 |
K032683 |
SMITH & NEPHEW, INC. |
GENESIS II POROUS PLUS HA KNEE SYSTEM |
10/15/2003 |
K030612 |
SMITH & NEPHEW, INC. |
GENESIS II TOTAL KNEE SYSTEM |
05/27/2003 |
K071790 |
SMITH & NEPHEW, INC. |
GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM |
08/17/2007 |
K211246 |
Smith & Nephew, Inc. |
LEGION CR Porous Plus HA Femoral Components |
05/24/2021 |
K100897 |
SMITH & NEPHEW, INC. |
LEGION POROUS + HA TIBIAL BASEPLATES |
05/13/2010 |
K210566 |
Smith & Nephew, Inc. |
LEGION Porous CR Narrow Femoral Components |
03/25/2021 |
K091543 |
SMITH & NEPHEW, INC. |
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS |
12/21/2009 |
K073325 |
SMITH & NEPHEW, INC. |
LEGION POROUS PRIMARY |
12/20/2007 |
K211221 |
Smith & Nephew, Inc. |
Porous Patella and Porous Tibia Baseplate |
10/01/2021 |
K030623 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM |
05/22/2003 |
K121393 |
SMITH & NEPHEW, INC. |
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION |
08/07/2012 |
K123486 |
Stryker |
TRIATHLON TRITANIUM TIBIAL BASEPLATE |
05/03/2013 |
K122053 |
STRYKER CORP. |
SHAPEMATCH CUTTING GUIDE |
10/24/2012 |
K110533 |
STRYKER CORP. |
STRYKER PATIENT SPECIFIC CUTTING GUIDE |
05/19/2011 |
K141056 |
STRYKER ORTHOPAEDICS |
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS |
08/05/2014 |
K072575 |
STRYKER ORTHOPAEDICS |
TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE |
01/07/2008 |
K173849 |
Stryker Orthopaedics |
Triathlon Total Knee System |
02/02/2018 |
K143393 |
STRYKER ORTHOPAEDICS |
Triathlon Tritanium Cone Augments |
01/13/2015 |
K132624 |
STRYKER ORTHOPAEDICS |
TRIATHLON TRITANIUM METAL-BACKED PATELLA |
11/26/2013 |
K162256 |
TOTAL JOINT ORTHOPEDICS, INC. |
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous |
10/27/2016 |
K193312 |
Unik Orthopedics, Inc. |
UNIKO PointCloudÖ Knee Instruments |
08/12/2020 |
K140075 |
UNITED ORTHOPEDIC CORP. |
U2 FEMORAL COMPONENT, CR, POROUS COATED |
06/13/2014 |
K150832 |
UNITED ORTHOPEDIC CORPORATION |
U2 Femoral Component, CR, Porous Coated, Additional Sizes |
09/25/2015 |
K221705 |
United Orthopedic Corporation |
U2 Total Knee System-PF+ |
02/28/2023 |
K201364 |
Waldemar Link GmbH & Co. KG |
LINK TrabecuLink Femoral Cones |
07/17/2020 |
K200113 |
Waldemar Link GmbH & Co. KG |
LINK TrabecuLink Tibial Cones |
03/18/2020 |
K081479 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ADVANCE A-CLASS TIBIAL INSERT |
02/20/2009 |
K043083 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL |
04/18/2005 |
K063128 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ADVANCE SPIKED POROUS TIBIAL BASE |
03/21/2007 |
K063731 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ADVANCE STATURE FEMORAL COMPONENT |
03/02/2007 |
K061223 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ADVANCE TOTAL KNEE SYSTEM |
08/18/2006 |
K122218 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ADVANCE TOTAL KNEE SYSTEM-PATELLA |
03/21/2013 |
K093405 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
05/25/2010 |
K103598 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
10/17/2011 |
K123459 |
ZIMMER INC. |
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM |
02/22/2013 |
K053340 |
ZIMMER TRABECULAR |
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS |
02/27/2006 |
K120990 |
ZIMMER TRABECULAR METAL TECHNOLOGY |
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL |
06/29/2012 |
K102896 |
ZIMMER TRABECULAR METAL TECHNOLOGY |
TRABECULAR METAL TIBIAL CONE AUGMENTS |
12/13/2010 |
K103517 |
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
TRABECULAR METAL FEMORAL CONE AUGMENTS |
02/15/2011 |
K070214 |
ZIMMER, INC. |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM |
03/16/2007 |
K071107 |
ZIMMER, INC. |
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON |
07/06/2007 |
K072619 |
ZIMMER, INC. |
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS |
11/21/2007 |
K041100 |
ZIMMER, INC. |
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS |
10/29/2004 |
K031061 |
ZIMMER, INC. |
NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS |
10/09/2003 |
K072160 |
ZIMMER, INC. |
NEXGEN TRABECULAR METAL TIBIAL TRAY |
09/05/2007 |
K141840 |
ZIMMER, INC. |
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH |
09/03/2014 |
K222566 |
Zimmer, Inc. |
Zimmer Persona Personalized Knee System |
10/17/2022 |
K150090 |
ZIMMER, INC. |
Zimmer Persona Personalized Knee System |
05/20/2015 |
K172524 |
Zimmer, Inc. |
Zimmer Persona Personalized Knee System |
05/17/2018 |
K173417 |
Zimmer, Inc. |
Zimmer Persona Personalized Knee System |
01/30/2018 |
K121771 |
ZIMMER, INC. |
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM |
11/07/2012 |
K122745 |
ZIMMER, INC. |
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM |
12/05/2012 |