Atlas FDA

HSX

114 FDA 510(k) clearances · Product code

88 daysmedian time to decision
239 days90th percentile
114clearances measured

FDA profile

Official device name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3520
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 240 · 2022: 257 · 2023: 231 · 2024: 172 · 2025: 178 · 2026: 75
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Tahoe Unicondylar Knee System with TiNbN Overcoat (K260796)Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics2026-04-02
Cambridge Partial Knee (K251771)Signature Orthopaedics Pty, Ltd.2025-12-16
Persona Partial Knee (K251834)Zimmer Biomet2025-08-15
MOTO Partial Knee System Extension (K251618)Medacta International S.A.2025-07-24
Arthrex iBalance Partial Knee System (K251453)Arthrex, Inc.2025-07-01
ACTIFY™ Unicondylar Knee System (K241260)Globus Medical, Inc.2024-12-06
JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (K242711)Smith & Nephew, Inc.2024-10-30
OvertureTi Knee Resurfacing SystemTM (K242746)Overture Orthopaedics2024-10-07
TRIBRID® Unicompartmental Knee System (K232114)Kyocera Medical Technologies, Inc.2024-04-04
Uni Knee Resurfacing System (K221292)Overture Resurfacing, Inc.2023-03-10
TLC Unicompartmental Knee System (K212870)Signature Orthopaedics Pty, Ltd.2022-06-16
Restoris Multi-Compartmental Knee System (K220930)Mako Surgical Corp.2022-06-02
Balanced Knee System Uni (K211471)Ortho Development Corporation2021-12-16
MOTOTM Partial Knee & MOTO PFJ Systems Extension (K213071)Medacta International S.A.2021-11-16
BC Reflex Uni Knee System (K212307)Bodycad Laboratories, Inc.2021-10-12
VISIONAIRE UK Patient Matched Cutting Guides (K211512)Smith & Nephew, Inc.2021-09-16
BC Reflex Uni Knee System (K211895)Bodycad Laboratories, Inc.2021-08-20
BC Reflex Uni Knee System (K203697)Bodycad Laboratories, Inc.2021-03-12
ACS LD Uni FB Knee System (K203341)Implantcast GmbH2021-01-08
Triathlon PKR System (K203099)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2020-10-27
Materialise PKA Guide System (K202207)Materialise NV2020-10-02
iBalance UKA Tibial Tray Implant (K200433)Arthrex, Inc.2020-03-17
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill (K200151)Zimmer, Inc.2020-03-17
BC Reflex Uni Knee System (K191996)Bodycad Laboratories, Inc.2019-12-05
Bodycad Unicompartmental Knee System (K191150)Bodycad Laboratories, Inc.2019-10-08
JOURNEY II Unicompartmental Knee System (K191211)Smith & Nephew, Inc.2019-07-25
EMPOWR Partial Knee (K191325)Encore Medical L.P.2019-07-16
Journey II Unicompartmental Knee System (K190085)Smith & Nephew, Inc.2019-02-11
MOTO Partial Knee System (K183029)Medacta International S.A.2019-01-30
Bodycad Unicompartmental Knee System (K181302)Bodycad Laboratories, Inc.2019-01-17
Materialise PKA Guide System (K173970)Materialise NV2018-07-06
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts (K180612)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2018-06-07
Materialise PKA Guide System (K172650)Materialise NV2017-11-20
Tahoe Uni Knee System (K170344)Consensus Orthopedics, Inc.2017-10-05
GMK UNI (K161741)Medacta International S.A.2017-04-14
Bodycad Unicompartmental Knee System (K163700)Bodycad Laboratories, Inc.2017-03-29
MOTO Partial Knee System (K162084)Medacta International S.A.2017-01-03
Arthrex iBalance UKA System Vitamin E Tibial Bearing (K161060)Arthrex, Inc.2016-12-15
Persona Partial Knee System (K161592)Biomet, Inc.2016-11-03
ZUK Select Knee System (K160738)Smith & Nephew, Inc.2016-06-15
JOURNEY II Uni Tibial Base and Insert (K152315)Smith & Nephew, Inc.2015-10-28
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K132640)Conformis, Inc.2013-12-05
STRIDE UNICONDYLAR KNEE (K123380)Blue Belt Technologies, Inc.2013-05-31
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE (K122529)Zimmer, Inc.2012-11-16
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K121974)Conformis, Inc.2012-09-06
HLS UNI EVOLUTION & U-KNEETEC (K120262)Tornier, Inc.2012-07-25
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER (K112301)Materialise NV2012-01-06
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS (K113038)Smith & Nephew, Inc.2012-01-05
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM (K111916)Conformis, Inc.2011-09-29
JOURNEY UNICONDYLAR TIBIAL BASEPLATES (K102069)Smith & Nephew, Inc.2010-10-05
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM (K101206)Alexandria Research Technologies, LLC2010-07-23
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS (K100197)Smith & Nephew, Inc.2010-02-19
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM (K092441)Conformis, Inc.2009-09-09
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM (K090024)Alexandria Research Technologies, LLC2009-05-04
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM (K082172)Mako Surgical Corporation2008-11-28
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III (K082081)Mako Surgical Corp.2008-10-15
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT (K081351)Smith & Nephew, Inc.2008-07-24
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II (K080368)Mako Surgical Corp.2008-06-20
JOURNEY UNICONDYLAR FEMORAL IMPLANT (K073175)Smith & Nephew, Inc.2007-12-20
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM (K073248)Mako Surgical Corp.2007-12-12
CONFORMIS UNI-CONDYLAR KNEE SYSTEM (K072586)Conformis, Inc.2007-11-08
CONFORMIS METAL BACKED TIBIAL COMPONENT (K072368)Conformis, Inc.2007-09-20
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) (K063432)Conformis, Inc.2007-03-16
ACCIN UNI-KNEE SYSTEM (K063782)Accin Corporation2007-01-19
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE (K061779)Smith & Nephew, Inc.2006-08-04
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE (K061011)Smith & Nephew, Inc.2006-07-11
ACCIN UNI-KNEE SYSTEM (K060670)Accin Corporation2006-06-02
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM (K060017)Mako Surgical Corp.2006-02-23
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS (K050373)Arthrosurface, Inc.2005-10-11
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD (K043570)Conformis, Inc.2005-03-14
EIUS UNICOMPARTMENTAL KNEE SYSTEM (K033769)Howmedica Osteonics Corp.2004-02-13
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM (K033363)Zimmer, Inc.2004-01-16
STELKAST UNICONDYLAR KNEE SYSTEM (K032824)Stelkast Company2003-11-13
HLS UNI EVOLUTION PROSTHESIS (K022211)Tornier2003-05-22
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE (K011954)Sulzer Orthopedics, Inc.2001-09-19
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) (K010685)Zimmer, Inc.2001-04-02
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM (K992287)Howmedica Osteonics Corp.1999-11-16
SLED UNICOMPARTMENT KNEE SYSTEM (K954186)Link America, Inc.1996-01-26
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES (K952068)Zimmer, Inc.1995-09-19
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (K942263)Zimmer, Inc.1995-07-11
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT (K945613)Howmedica Corp.1995-03-06
PRESERVATION UNICOMPARTMENTAL KNEE (K941606)Depuy, Inc.1994-10-14
P.C.A. MODULAR KNEE SYSTEM (K931214)Howmedica Corp.1994-02-15
DURACON UNICOMPARTMENTAL KNEE SYSTEM (K926231)Howmedica Corp.1993-03-30
KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM (K922824)Joint Medical Products Corp.1992-09-17
KEANE UNI KNEE SYSTEM WITH POROCOAT (K921232)Depuy, Inc.1992-06-09
NATURAL-KNEE TIBIAL AND FEMORAL SPACERS (K915240)Intermedics Orthopedics1992-01-31
GENESIS UNICOMPARTMENTAL KNEE SYSTEM (K912735)Smith & Nephew Richards, Inc.1991-12-27
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL (K914439)Johnson & Johnson Orthopaedics, Inc.1991-10-23
KEANE UNI KNEE SYSTEM (K910807)Depuy, Inc.1991-06-27
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES (K910083)Osteonics Corp.1991-04-01
CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION (K903286)Techmedica, Inc.1990-10-12
CAAS UNICOMPARMENTAL KNEE SYSTEM (K900619)Techmedica, Inc.1990-06-11
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM (K896648)Concept, Inc.1990-06-05
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS (K896856)Osteonics Corp.1990-02-06
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM (K894068)Kirschner Medical Corp.1989-12-08
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM (K881779)Dow Corning Wright1988-08-31
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE (K880155)Zimmer, Inc.1988-08-03
KIRSCHNER UNICONDYLAR KNEE SYSTEM (K873970)Kirschner Medical Corp.1987-12-31
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. (K872735)Howmedica Corp.1987-08-04
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