510(k) K251292

RECLAIM Monobloc Revision Femoral Stem by Depuy Ireland UC — Product Code LZO

K251292 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "RECLAIM Monobloc Revision Femoral Stem". The FDA issued a decision of Substantially Equivalent on May 23, 2025. 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. Depuy Ireland UC has at least 10 other 510(k) clearances on record.