510(k) K243192

iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating by Nextstep Arthopedix, LLC — Product Code LPH

K243192 is an FDA 510(k) premarket notification submitted by Nextstep Arthopedix, LLC for the device "iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating". The FDA issued a decision of Substantially Equivalent on June 5, 2026. 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.