Cleared Special

CATALYSTEM Femoral Stems

K250571 · Smith & Nephew, Inc. · Orthopedic
Mar 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K250571 is an FDA 510(k) clearance for the CATALYSTEM Femoral Stems, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on March 28, 2025, 30 days after receiving the submission on February 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K250571 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2025
Decision Date March 28, 2025
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3353

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