Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems

About This 510(k) Submission

K240783 is an FDA 510(k) clearance for the Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on October 21, 2024, 214 days after receiving the submission on March 21, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.