510(k) K253434

OSSTM Orthopedic Salvage System by Biomet, Inc. — Product Code JDI

K253434 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "OSSTM Orthopedic Salvage System". The FDA issued a decision of Substantially Equivalent on July 1, 2026. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biomet, Inc. has at least 10 other 510(k) clearances on record.