510(k) K211703

Insignia Hip Stem by Stryker Orthopaedics — Product Code MEH

K211703 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "Insignia Hip Stem". The FDA issued a decision of Substantially Equivalent on August 16, 2021. 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 Orthopaedics has at least 10 other 510(k) clearances on record.