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FX Shoulder Solutions received FDA 510(k) clearance for the FX V135 Easytech Shoulder System, the next generation of stemless shoulder arthroplasty implants that provides surgeons with an anatomic stemless versus a modular stemmed-reverse option. This design enables surgeons to begin with a stemless approach and, when clinically appropriate, transition intraoperatively to a short stem solution without changing or adding another system.
This entire workflow is supported through one humeral tray. The system is claimed to be the only one in the USA with a modular construct that integrates a stemless anchor base with a removable (anatomic) stem adaptation into a single humeral platform.
FX V135 Easytech is available in the Anatomic Configuration as a Stemless with optional short stem conversion, in the Reverse Configuration with the short stem option. Both the anatomic and reverse configurations are at 135°, while the reverse configuration allows for a 145° option. The anchor base sizes are 32mm, 36mm, 38mm, 40mm, 44mm, and the humeral stem adaptation is 8mm in diameter. The system is compatible with previously cleared humeral head and glenoid options for the anatomic and glenoid baseplate and glenosphere options for the reverse.
The FX V135 Easytech builds upon the FX V135 platform (Mini, Humelock, Long) with enhancements designed to improve precision, including centered humeral cup tapers, the introduction of a +1mm humeral cup option (previously +3mm minimum), and greater ability to fine-tune soft tissue tensioning intraoperatively.
“This clearance represents a significant step forward in our mission to simplify complexity without limiting surgeon choices,” said Baptiste Martin, CEO of FX Shoulder Solutions. “FX V135 Easytech is designed to give surgeons the flexibility to adapt in real time—moving from stemless to stemmed fixation within a single system—while maintaining the efficiency of a single-tray solution which allows an easy adaptation to ASC market. This is a continuation of what has defined FX since the beginning: purposeful innovation that respects both surgical workflow and patient-specific needs. It is the continuation of our new generation FX V135 portfolio.”
Source: FX Shoulder Solutions, Inc.
FX Shoulder Solutions received FDA 510(k) clearance for the FX V135 Easytech Shoulder System, the next generation of stemless shoulder arthroplasty implants that provides surgeons with an anatomic stemless versus a modular stemmed-reverse option. This design enables surgeons to begin with a stemless approach and, when clinically appropriate,...
FX Shoulder Solutions received FDA 510(k) clearance for the FX V135 Easytech Shoulder System, the next generation of stemless shoulder arthroplasty implants that provides surgeons with an anatomic stemless versus a modular stemmed-reverse option. This design enables surgeons to begin with a stemless approach and, when clinically appropriate, transition intraoperatively to a short stem solution without changing or adding another system.
This entire workflow is supported through one humeral tray. The system is claimed to be the only one in the USA with a modular construct that integrates a stemless anchor base with a removable (anatomic) stem adaptation into a single humeral platform.
FX V135 Easytech is available in the Anatomic Configuration as a Stemless with optional short stem conversion, in the Reverse Configuration with the short stem option. Both the anatomic and reverse configurations are at 135°, while the reverse configuration allows for a 145° option. The anchor base sizes are 32mm, 36mm, 38mm, 40mm, 44mm, and the humeral stem adaptation is 8mm in diameter. The system is compatible with previously cleared humeral head and glenoid options for the anatomic and glenoid baseplate and glenosphere options for the reverse.
The FX V135 Easytech builds upon the FX V135 platform (Mini, Humelock, Long) with enhancements designed to improve precision, including centered humeral cup tapers, the introduction of a +1mm humeral cup option (previously +3mm minimum), and greater ability to fine-tune soft tissue tensioning intraoperatively.
“This clearance represents a significant step forward in our mission to simplify complexity without limiting surgeon choices,” said Baptiste Martin, CEO of FX Shoulder Solutions. “FX V135 Easytech is designed to give surgeons the flexibility to adapt in real time—moving from stemless to stemmed fixation within a single system—while maintaining the efficiency of a single-tray solution which allows an easy adaptation to ASC market. This is a continuation of what has defined FX since the beginning: purposeful innovation that respects both surgical workflow and patient-specific needs. It is the continuation of our new generation FX V135 portfolio.”
Source: FX Shoulder Solutions, Inc.
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
