510(k) K252401

implaFit® short stems by Implantcast GmbH — Product Code LZO

K252401 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "implaFit® short stems". The FDA issued a decision of Substantially Equivalent on March 12, 2026. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Implantcast GmbH has at least 10 other 510(k) clearances on record.