510(k) K213129

Restoration Modular 115mm Conical Distal Stem by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LZO

K213129 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics for the device "Restoration Modular 115mm Conical Distal Stem". The FDA issued a decision of Substantially Equivalent on Dec 21, 2021. 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. Howmedica Osteonics Corp., Dba Stryker Orthopaedics has 30 other 510(k) clearances on record.