510(k) K946236

PROFIX CONFORMING PLUS TIBIAL INSERT by Smith & Nephew Richards, Inc. — Product Code KWH

K946236 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "PROFIX CONFORMING PLUS TIBIAL INSERT". The FDA issued a decision of Substantially Equivalent on July 6, 1995. The device falls under product code KWH (Prosthesis, Toe, Constrained, Polymer), a Class II device regulated under 21 CFR 888.3720. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.