Cleared Traditional

Ceramic Femoral Head

K240452 · Microport Orthopedics, Inc. · Orthopedic
Apr 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K240452 is an FDA 510(k) clearance for the Ceramic Femoral Head, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on April 12, 2024, 57 days after receiving the submission on February 15, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K240452 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2024
Decision Date April 12, 2024
Days to Decision 57 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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