510(k) K220731

Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem by Stryker — Product Code MEH

K220731 is an FDA 510(k) premarket notification submitted by Stryker for the device "Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem". The FDA issued a decision of Substantially Equivalent on August 11, 2022. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Stryker has at least 10 other 510(k) clearances on record.