Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FDA product code JWH · 861 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3560
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-07-20 – 2026-09-15
JWH
2021-07-13
JWH
2021-05-18
Persona Revision Knee System Femoral Metaphyseal Cones
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JWH
2021-05-13
GMK Spherika Femurs and Fixed Tibial Trays Plus
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JWH
2021-05-13
LinkSymphoKnee System
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JWH
2021-05-12
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
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JWH
2021-05-06
Identity Imprint Knee Replacement System
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JWH
2021-05-05
Genius / Genuin Total Knee System
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JWH
2021-04-21
U2 Total Knee System, XPE Tibial Insert, PS PLUS
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JWH
2021-04-21
MOBIO Total Knee System
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JWH
2021-04-02
Apex Knee System
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JWH
2021-03-18
Persona Revision Knee System
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JWH
2021-02-17
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System
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JWH
2020-12-28
Attune Revision Sleeve LPS Femoral Adaptors
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JWH
2020-12-22
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement
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JWH
2020-12-11
GMK Total Knee System - TiNbN Coating
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JWH
2020-11-18
Freedom(R) - TiNbN Coated Knee
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JWH
2020-10-23
Mobio Total Knee System
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JWH
2020-10-09
Klassic Knee System Tibial Inserts, PS-Max
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JWH
2020-09-18
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)
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JWH
2020-07-30
EXULT Femoral component trial - Left, EXULT Femoral component trial - Right
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JWH
2020-07-10
Triathlon Total KneeSystem
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JWH
2020-06-16
iTotal® Identity Posterior Stabilized Knee Replacement System
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JWH
2020-06-16
TRUMATCH Personalized Solutions
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JWH
2020-06-04
Journey II XR Knee Instrument
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JWH
2020-05-07
AMF Revision TT Cones
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JWH
2020-05-07
LOSPA II Knee System (EXULT Knee Replacement System)
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JWH
2020-04-24
Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks
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JWH
2020-03-24
Persona Personalized Knee System
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JWH
2020-03-13
LEGION Inserts with JRNY Lock
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JWH
2020-03-13
3DMetal Diaphyseal Femoral Cones
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JWH
2020-03-13
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System
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JWH
2020-01-31
Physica LMC Knee System
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JWH
2020-01-30
ATTUNE All-Polyethylene Tibia
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JWH
2020-01-24
Persona Personalized Knee System
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JWH
2019-12-11
LOSPA II Knee System
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JWH
2019-11-27
World Knee Total Knee Systems
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JWH
2019-11-26
Physica KR Liner and SMR Reverse Humeral Liner
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JWH
2019-11-08
PFC SIGMA Knee System
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JWH
2019-10-22
Madison Total Knee System
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JWH
2019-09-25
OMNI TiN Coated Apex Knee™ System
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JWH
2019-09-05
Freedom Primary PCK
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JWH
2019-09-05
Persona Revision Knee System
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JWH
2019-08-22
Triathlon Total Knee System-Additional Components
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JWH
2019-08-08
iTotal Identity Cruciate Retaining Knee Replacement System
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JWH
2019-08-01
SurgTech GENOLL Total Knee System
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JWH
2019-07-25
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
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JWH
2019-07-18
SPAR-K Instruments (for use with Gemini SL Total Knee System)
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JWH
2019-06-20
Renovis A200 PS Knee System as part of the Renovis A200 Knee System
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JWH
2019-06-04
Vanguard XP Knee System
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JWH
2019-06-04
Unity Total Knee System
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JWH
2019-05-16
Precision Casting Solutions Total Knee System
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JWH
2019-05-16
EVOLUTION NitrX Medial-Pivot Knee
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JWH
2019-05-10
Vanguard Complete Knee System
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JWH
2019-04-27
InterSpace Knee Extra-Large Size, InterSpace Knee ATS
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JWH
2019-04-03
LINK GEMINI SL Total Knee System
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JWH
2019-03-29
Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
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JWH
2019-03-18
The Progressive Orthopaedic Company Total Knee System II
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JWH
2019-03-15
Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly
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JWH
2019-02-15
Stabil Orthopaedic Solutions Total Knee System
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JWH
2019-01-28
MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
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JWH
2019-01-22
Freedom Ultra-Congruent CR Tibial Liner
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JWH
2019-01-17
Imboki Knee Instrument System
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JWH
2018-12-06
EVOLUTION Stemmed CS Femur
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JWH
2018-11-28
Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
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JWH
2018-10-31
Balanced Knee Revision System Trabecular Tibial Cone Augments
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JWH
2018-10-25
Persona Revision Knee System
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JWH
2018-10-24
World Total Knee System
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JWH
2018-10-12
BKS Revision Sleeves System
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JWH
2018-10-12
b-ONE Total Knee System
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JWH
2018-09-27
Acculoc Total Knee System
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JWH
2018-08-23
GMK Sphere CR Tibial Inserts
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JWH
2018-08-23
GMK Sphere - Kinematic Alignment
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JWH
2018-08-03
ASK System
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JWH
2018-07-09
EMPOWR VVC TIBIAL INSERT
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JWH
2018-06-22
A3 Total Knee System
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JWH
2018-06-20
Balanced Knee Revision System - Offset Junction Box
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JWH
2018-05-16
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
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JWH
2018-04-20
World Knee System
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JWH
2018-03-29
Zimmer Knee Joint Replacement Prostheses MR Labeling
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JWH
2018-03-23
Acculoc Total Knee System
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JWH
2018-03-09
Klassic® Knee System
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JWH
2018-03-05
LEGION Knee System
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JWH
2018-03-05
EMPOWR Universal Tibial Baseplate
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JWH
2018-02-02
Materialise TKA Guide System
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JWH
2018-01-19
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
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JWH
2018-01-17
Unity Total Knee System
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JWH
2018-01-10
Smith & Nephew Patient Matched Cutting Blocks
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JWH
2017-12-28
X-PSI Knee System
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JWH
2017-11-30
Destiknee™ Total Knee System
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JWH
2017-11-16
JOURNEY II XR Knee Instruments
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JWH
2017-11-09
PROLIXUS TOTAL KNEE SYSTEM
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JWH
2017-10-30
Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System
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JWH
2017-10-20
MyKnee PPS-Pin Positioners
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JWH
2017-08-18
3DMetal Tibial Cones
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JWH
2017-08-09
CKS Plus Knee System
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JWH
2017-08-08
EVOLUTION Revision CCK System
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JWH
2017-07-28
Biomet Knee Joint Replacement Prostheses
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JWH
2017-07-17
Genius Total Knee System
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JWH
2017-07-13
Unity Total Knee System
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JWH
2017-06-15
ATTUNE Cemented Tibial Base, Fixed Bearing
View details →No matching devices.
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