510(k) K152454

HemiCAP MTP Resurfacing Hemi-Arthroplasty System by Arthrosurface, Inc. — Product Code KWD

K152454 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "HemiCAP MTP Resurfacing Hemi-Arthroplasty System". The FDA issued a decision of Substantially Equivalent on April 11, 2016. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.