Cleared Traditional

Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners

K243571 · Zimmer Biomet · Orthopedic
Jul 2025
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K243571 is an FDA 510(k) clearance for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Zimmer Biomet (Warsaw, US). The FDA issued a Cleared decision on July 31, 2025, 255 days after receiving the submission on November 18, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K243571 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2024
Decision Date July 31, 2025
Days to Decision 255 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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