Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
FDA product code HSX · 114 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3520
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-11-30 – 2026-08-04
HSX
2026-08-04
HSX
2026-04-02
Tahoe Unicondylar Knee System with TiNbN Overcoat
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HSX
2025-12-16
Cambridge Partial Knee
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HSX
2025-08-15
Persona Partial Knee
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HSX
2025-07-24
MOTO Partial Knee System Extension
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HSX
2025-07-01
Arthrex iBalance Partial Knee System
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HSX
2024-12-06
ACTIFY™ Unicondylar Knee System
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HSX
2024-10-30
JOURNEY II Unicompartmental Knee System (JOURNEY II UK)
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HSX
2024-10-07
OvertureTi Knee Resurfacing SystemTM
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HSX
2024-04-04
TRIBRID® Unicompartmental Knee System
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HSX
2023-03-10
Uni Knee Resurfacing System
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HSX
2022-06-16
TLC Unicompartmental Knee System
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HSX
2022-06-02
Restoris Multi-Compartmental Knee System
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HSX
2021-12-16
Balanced Knee System Uni
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HSX
2021-11-16
MOTOTM Partial Knee & MOTO PFJ Systems Extension
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HSX
2021-10-12
BC Reflex Uni Knee System
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HSX
2021-09-16
VISIONAIRE UK Patient Matched Cutting Guides
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HSX
2021-08-20
BC Reflex Uni Knee System
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HSX
2021-03-12
BC Reflex Uni Knee System
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HSX
2021-01-08
ACS LD Uni FB Knee System
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HSX
2020-10-27
Triathlon PKR System
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HSX
2020-10-02
Materialise PKA Guide System
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HSX
2020-03-17
iBalance UKA Tibial Tray Implant
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HSX
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
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HSX
2019-12-05
BC Reflex Uni Knee System
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HSX
2019-10-08
Bodycad Unicompartmental Knee System
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HSX
2019-07-25
JOURNEY II Unicompartmental Knee System
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HSX
2019-07-16
EMPOWR Partial Knee
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HSX
2019-02-11
Journey II Unicompartmental Knee System
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HSX
2019-01-30
MOTO Partial Knee System
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HSX
2019-01-17
Bodycad Unicompartmental Knee System
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HSX
2018-07-06
Materialise PKA Guide System
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HSX
2018-06-07
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
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HSX
2017-11-20
Materialise PKA Guide System
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HSX
2017-10-05
Tahoe Uni Knee System
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HSX
2017-04-14
GMK UNI
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HSX
2017-03-29
Bodycad Unicompartmental Knee System
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HSX
2017-01-03
MOTO Partial Knee System
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HSX
2016-12-15
Arthrex iBalance UKA System Vitamin E Tibial Bearing
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HSX
2016-11-03
Persona Partial Knee System
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HSX
2016-06-15
ZUK Select Knee System
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HSX
2013-12-05
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
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HSX
2013-05-31
STRIDE UNICONDYLAR KNEE
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HSX
2012-11-16
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
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HSX
2012-09-06
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
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HSX
2012-07-25
HLS UNI EVOLUTION & U-KNEETEC
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HSX
2012-01-06
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
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HSX
2012-01-05
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
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HSX
2011-09-29
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
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HSX
2010-10-05
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
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HSX
2010-07-23
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM
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HSX
2010-02-19
GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS
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HSX
2009-09-09
MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM
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HSX
2009-05-04
TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY SYSTEM
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HSX
2008-11-28
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
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HSX
2008-10-15
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
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HSX
2008-07-24
MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT
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HSX
2008-06-20
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
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HSX
2007-12-20
JOURNEY UNICONDYLAR FEMORAL IMPLANT
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HSX
2007-12-12
MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
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HSX
2007-11-08
CONFORMIS UNI-CONDYLAR KNEE SYSTEM
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HSX
2007-09-20
CONFORMIS METAL BACKED TIBIAL COMPONENT
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HSX
2007-03-16
CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
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HSX
2007-01-19
ACCIN UNI-KNEE SYSTEM
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HSX
2006-08-04
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE
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HSX
2006-07-11
COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE
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HSX
2006-06-02
ACCIN UNI-KNEE SYSTEM
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HSX
2006-02-23
MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
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HSX
2005-10-11
UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
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HSX
2005-03-14
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
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HSX
2004-02-13
EIUS UNICOMPARTMENTAL KNEE SYSTEM
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HSX
2004-01-16
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
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HSX
2003-11-13
STELKAST UNICONDYLAR KNEE SYSTEM
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HSX
2003-05-22
HLS UNI EVOLUTION PROSTHESIS
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HSX
2001-09-19
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
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HSX
2001-04-02
MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE)
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HSX
1999-11-16
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
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HSX
1996-01-26
SLED UNICOMPARTMENT KNEE SYSTEM
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HSX
1995-09-19
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES
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HSX
1995-07-11
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM
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HSX
1995-03-06
DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT
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HSX
1994-10-14
PRESERVATION UNICOMPARTMENTAL KNEE
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HSX
1994-02-15
P.C.A. MODULAR KNEE SYSTEM
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HSX
1993-03-30
DURACON UNICOMPARTMENTAL KNEE SYSTEM
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HSX
1992-09-17
KNEE JT. PATELLO FEMORO TIBIAL POLYMER/METAL/POLYM
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HSX
1992-06-09
KEANE UNI KNEE SYSTEM WITH POROCOAT
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HSX
1992-01-31
NATURAL-KNEE TIBIAL AND FEMORAL SPACERS
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HSX
1991-12-27
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
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HSX
1991-10-23
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL
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HSX
1991-06-27
KEANE UNI KNEE SYSTEM
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HSX
1991-04-01
OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES
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HSX
1990-10-12
CONTINUUM KNEE SYSTEM (CKS)-MODIFICATION
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HSX
1990-06-11
CAAS UNICOMPARMENTAL KNEE SYSTEM
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HSX
1990-06-05
CONCEPT UNICOMPARTMENTAL KNEE SYSTEM
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HSX
1990-02-06
MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
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HSX
1989-12-08
KIRSCHNER UNICOMPARTMENTAL KNEE SYSTEM
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HSX
1988-08-31
WHITESIDE ORTHOLOC II UNICONDYLAR KNEE SYSTEM
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HSX
1988-08-03
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE
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HSX
1987-12-31
KIRSCHNER UNICONDYLAR KNEE SYSTEM
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HSX
1987-08-04
HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
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