DePuy SUMMIT Porocoat Hip Prosthesis ? MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis ? MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis ? MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis ? MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis ? MR Conditional

About This 510(k) Submission

K231873 is an FDA 510(k) clearance for the DePuy SUMMIT Porocoat Hip Prosthesis ? MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis ? MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis ? MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis ? MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis ? MR Conditional, a Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (Class II — Special Controls, product code MEH), submitted by Depuy Ireland UC (Ringaskiddy, IE). The FDA issued a Cleared decision on January 19, 2024, 207 days after receiving the submission on June 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.