FX Shoulder USA Gets 510(k) Clearance for Shoulder Arthroplasty Devices
FX Shoulder USA has received 510(k) clearance from the FDA for its Humelock lateralized and augmented glenoid baseplates used in shoulder arthroplasty.
The Humelock baseplates for the glenoid — the shallow socket in the shoulder blade at the head of the upper arm bone — are available with additional components that can be placed under the flat surface of the baseplate to adjust for the individual patient. Lateralization refers to localization of function on one side in preference to the other.
“As we continue to grow the FX portfolio, we evolve ever closer to providing a tailor-made approach for surgeons … [who] may be able to adapt the system to the patient rather than the patient to our system,” said Baptiste Martin, CEO of FX Shoulder USA.