510(k) K242045

Initia T3 Acetabular Hemispherical Shell System by Kyocera Medical Technologies, Inc. — Product Code LPH

K242045 is an FDA 510(k) premarket notification submitted by Kyocera Medical Technologies, Inc. for the device "Initia T3 Acetabular Hemispherical Shell System". The FDA issued a decision of Substantially Equivalent on April 10, 2025. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Kyocera Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.