510(k) K111068

STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5 by Skeletal Dynamics, LLC — Product Code KYI

K111068 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, LLC for the device "STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5". The FDA issued a decision of Substantially Equivalent on December 30, 2011. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Skeletal Dynamics, LLC has at least 10 other 510(k) clearances on record.