Medacta Gains CE Mark for Shoulder Implants
The two components allow surgeons to widen clinical use of the system by addressing more patient morphologies and pathologies.
Regulatory
Articles
Medacta Expands its Hip and Shoulder Portfolio
Medacta gained FDA clearance for its M-Vizion Femoral Revision System and its Long Humeral Diaphysis for shoulder joint replacement.
OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet’s Persona Knee
OrthoSensor was granted FDA 510(k) clearance for Alignment capabilities with VERASENSE™ Sensor-Assisted Technology for use with Zimmer Biomet's Persona Knee.
Extremity Medical Gains FDA Clearance for KinematX Total Wrist
Extremity Medical received FDA 510(k) clearance for the KinematX Total Wrist. Launch will occur by the end of 2020.
DePuy Synthes Announces CE Mark for BI-MENTUM Dual Mobility Hip
DePuy Synthes has been informed of CE Mark approval for the BI-MENTUM™ Dual Mobility hip for patients with a higher dislocation risk.
In2Bones Gains FDA Clearance for Quantum Total Ankle
In2Bones received FDA 510(k) clearance to market the Quantum™ Total Ankle.
Rejoint YourKnee Receives CE Mark Approval
REJOINT received CE Mark approval for the YourKnee™ patient-specific 3D-printed total knee replacement.
Episurf Medical receives CE Mark for Episealer Talus and Talus Osteotomy Guide
Episurf Medical received approval under the CE Mark for the Episealer® Talus and Talus Osteotomy Guide.
Episurf Medical Patent and Regulatory Updates
Episurf Medical received an additional patent in China relative to the Episealer® Femoral Twin joint implant design process and expects to obtain CE Mark Approval for the Episealer Talus ankle implant.
Medacta Gains FDA Clearance for MyShoulder Placement Guides
Medacta was granted FDA 510(k) clearance to market MyShoulder Placement Guides for use with the Medacta Shoulder and associated instrumentation.