Atlas FDA

MBH

143 FDA 510(k) clearances · Product code

90 daysmedian time to decision
247 days90th percentile
143clearances measured

FDA profile

Official device name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3565
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 1,539 · 2022: 1,261 · 2023: 1,263 · 2024: 1,497 · 2025: 1,576 · 2026: 939
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
Zimmer® Persona® Personalized Knee System (K251840)Zimmer, Inc.2026-05-28
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (K253189)Zimmer, Inc.2026-03-09
GMK 3D Metal Tibial Tray Extension (K253328)Medacta International S.A.2026-02-26
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (K253637)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026-02-18
Active-V Total Knee System; World Total Knee System (K253239)Signature Orthopaedics Pty, Ltd.2025-12-23
Balanced Knee System TriMax Porous Femoral Components (K253161)Ortho Development Corp.2025-12-19
Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (K252777)Maxx Orthopedics, Inc.2025-10-31
Triathlon® Total Knee System - Triathlon® Gold Femoral Components (K252044)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-10-24
U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (K243656)United Orthopedic Corporation2025-07-31
Physica System (Physica CR Porous Femoral components) (K250980)Lima Corporate S.P.A.2025-05-22
iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (K243768)Restor3D, Inc.2025-03-27
Freedom® Total Knee System - Porous Tibial Base Plate (K241597)Maxx Orthopedics, Inc.2025-02-13
Zimmer® Persona® Personalized Knee System (K243293)Zimmer Biomet2024-12-20
Physica Porous Femoral Components (K243615)Lima Corporate S.P.A.2024-12-18
Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (K242543)Zimmer, Inc.2024-11-22
Agility Symmetric™ Total Knee System (K242412)Medisurge, LLC2024-11-06
Persona the Personalized Knee System (K243247)Zimmer, Inc.2024-10-29
Exactech® TRULIANT® Knee System (K240393)Exactech, Inc.2024-10-03
The Optimotion™ Blue Plus Knee System (K240938)Optimotion Implants, LLC2024-06-27
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology (K240678)Depuy Ireland UC2024-06-18
Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) (K240299)Zimmer, Inc.2024-04-26
EVOLUTION® Tibial Cones (K233507)Microport Orthopedics, Inc.2024-01-18
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K232303)Depuy Ireland UC2023-12-11
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts (K232426)Conformis, Inc.2023-09-08
Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316)Conformis, Inc.2023-07-21
ATTUNE® Revision Cones (K230295)Depuy Ireland UC2023-03-10
U2 Total Knee System-PF+ (K221705)United Orthopedic Corporation2023-02-28
GMK Sphere & GMK SpheriKA Cementless (K223548)Medacta International S.A.2023-01-20
Zimmer Persona Personalized Knee System (K222566)Zimmer, Inc.2022-10-17
ATTUNE Revision Cones (K212746)Depuy Ireland UC2022-10-17
GMK 3D Metal Tibial Tray (K221850)Medacta International S.A.2022-08-23
Optimotion Implants Porous Metal-Backed Patella (K220049)Optimotion Implants, LLC2022-03-14
Porous Patella (K212941)Encore Medical, L.P. Dba Djo Surgical2022-01-20
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP (K213781)Depuy Ireland UC2022-01-18
MPO Knee Instruments; MPO PROPHECY Knee Instruments (K213817)Microport Orthopedics, Inc.2022-01-05
Porous Patella and Porous Tibia Baseplate (K211221)Smith & Nephew, Inc.2021-10-01
Symmetric Total Knee System (K203779)Signal Medical Corporation2021-06-10
LEGION CR Porous Plus HA Femoral Components (K211246)Smith & Nephew, Inc.2021-05-24
Physica system (K210554)Lima Corporate S.P.A.2021-04-06
EMPOWR Porous Femur with HAnano SurfaceTM (K210308)Encore Medical L.P.2021-03-30
LEGION Porous CR Narrow Femoral Components (K210566)Smith & Nephew, Inc.2021-03-25
Physica system (K201084)Lima Corporate S.P.A.2020-12-14
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K202194)Depuy Ireland UC2020-11-25
UNIKO PointCloud™ Knee Instruments (K193312)Unik Orthopedics, Inc.2020-08-12
LINK TrabecuLink Femoral Cones (K201364)Waldemar Link GmbH & Co. KG2020-07-17
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite (K200782)Howmedica Osteonics Corp.2020-05-13
The Optimotion Blue Total Knee System (K191084)Optimotion Implants, LLC2020-04-07
LINK TrabecuLink Tibial Cones (K200113)Waldemar Link GmbH & Co. KG2020-03-18
Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment (K190991)Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)2019-08-15
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (K182346)Exactech, Inc.2018-11-26
Truliant Porous Femoral Components (K181794)Exactech, Inc.2018-09-28
Zimmer Persona Personalized Knee System (K172524)Zimmer, Inc.2018-05-17
EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System (K180317)Microport Orthopedics, Inc.2018-05-04
Triathlon Total Knee System (K173849)Stryker Orthopaedics2018-02-02
Zimmer Persona Personalized Knee System (K173417)Zimmer, Inc.2018-01-30
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components (K172634)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017-11-16
Arthrex Knee Systems (K171365)Arthrex, Inc.2017-11-07
EMPOWR Porous Knee System (K171991)Encore Medical L.P.2017-10-04
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell (K170288)Microport Orthopedics, Inc.2017-06-15
Klassic Femur, Porous, Klassic Tibial Baseplate, Porous (K162256)Total Joint Orthopedics, Inc.2016-10-27
Vanguard XP Knee System (K153657)Biomet, Inc.2016-05-10
Optetrak One Logic Femoral Components (K153776)Exactech, Inc.2016-03-10
Arthrex iBalance TKA System (K153586)Arthrex, Inc.2016-02-19
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base (K152298)Microport Orthopedics, Inc.2015-11-16
Arthrex iBalance TKA System (K152252)Arthrex, Inc.2015-11-16
U2 Femoral Component, CR, Porous Coated, Additional Sizes (K150832)United Orthopedic Corporation2015-09-25
Freedom Cementless Femoral Component (K150680)Maxx Orthopedics, Inc.2015-06-26
Zimmer Persona Personalized Knee System (K150090)Zimmer, Inc.2015-05-20
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS (K140881)Depuy(Ireland)2015-02-13
ADVANCE Porous Coated Spiked Tibial Base (K143366)Microport Orthopedics, Inc.2015-01-21
Triathlon Tritanium Cone Augments (K143393)Stryker Orthopaedics2015-01-13
VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL (K141407)Biomet, Inc.2014-10-27
ARTHREX IBALANCE TKA SYSTEM (K141635)Arthrex, Inc.2014-09-03
TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH (K141840)Zimmer, Inc.2014-09-03
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS (K140735)Microport Orthopedics, Inc.2014-08-29
TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (K141056)Stryker Orthopaedics2014-08-05
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT (K140883)Biomet, Inc.2014-07-30
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS (K140302)Exactech, Inc.2014-07-30
U2 FEMORAL COMPONENT, CR, POROUS COATED (K140075)United Orthopedic Corp.2014-06-13
SIGNATURE PLANNER, SIGNATURE GUIDES (K140257)Materialise NV2014-04-02
VANGUARD XP KNEE SYSTEM (K132873)Biomet, Inc.2013-12-11
TRIATHLON TRITANIUM METAL-BACKED PATELLA (K132624)Stryker Orthopaedics2013-11-26
TRIATHLON TRITANIUM TIBIAL BASEPLATE (K123486)Stryker2013-05-03
ADVANCE TOTAL KNEE SYSTEM-PATELLA (K122218)Wrightmedicaltechnologyinc2013-03-21
VANGUARD XP KNEE SYSTEM (K122160)Biomet Manufacturing Corp2013-03-20
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM (K123459)Zimmer, Inc.2013-02-22
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM (K122745)Zimmer, Inc.2012-12-05
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM (K121771)Zimmer, Inc.2012-11-07
SHAPEMATCH CUTTING GUIDE (K122053)Stryker Corp.2012-10-24
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION (K121393)Smith & Nephew, Inc.2012-08-07
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL (K120990)Zimmer Trabecular Metal Technology2012-06-29
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES (K103598)Wrightmedicaltechnologyinc2011-10-17
CONSENSUS KNEE SYSTEM (K110950)Consensus Orthopedics, Inc.2011-06-27
STRYKER PATIENT SPECIFIC CUTTING GUIDE (K110533)Stryker Corp.2011-05-19
TRABECULAR METAL FEMORAL CONE AUGMENTS (K103517)Zimmer Trabecular Metal Technology, Inc.2011-02-15
CONSENSUS KNEE SYSTEM (K102927)Consensus Orthopedics, Inc.2011-01-26
TRABECULAR METAL TIBIAL CONE AUGMENTS (K102896)Zimmer Trabecular Metal Technology2010-12-13
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES (K093405)Wrightmedicaltechnologyinc2010-05-25
LEGION POROUS + HA TIBIAL BASEPLATES (K100897)Smith & Nephew, Inc.2010-05-13
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 (K093533)Materialise NV2010-02-17
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Every clearance here is in the API, with alerts when new ones post.