Cleared Traditional

CATALYSTEM Femoral Stems

K240381 · Smith & Nephew, Inc. · Orthopedic
Jun 2024
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K240381 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 June 27, 2024, 140 days after receiving the submission on February 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K240381 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2024
Decision Date June 27, 2024
Days to Decision 140 days
Submission Type Traditional
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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