510(k) K212187

Restoration® Modular Hip System by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LPH

K212187 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Restoration® Modular Hip System". The FDA issued a decision of Substantially Equivalent on March 1, 2022. 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. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has at least 10 other 510(k) clearances on record.