Cleared Traditional

ZCA All-Poly Acetabular Cups

K191449 · Zimmer, Inc. · Orthopedic
Jul 2020
Decision
412d
Days
Class 2
Risk

About This 510(k) Submission

K191449 is an FDA 510(k) clearance for the ZCA All-Poly Acetabular Cups, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 16, 2020, 412 days after receiving the submission on May 31, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K191449 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2019
Decision Date July 16, 2020
Days to Decision 412 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

Similar Devices — JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 561
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
K243571 · Zimmer Biomet · Jul 2025
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
K240783 · Smith & Nephew, Inc. · Oct 2024
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
K241716 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Aug 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2024
Global Modular Replacement System
K233261 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · Dec 2023
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
K222056 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Jan 2023