Cleared Traditional

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

K222056 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic
Jan 2023
Decision
198d
Days
Class 2
Risk

About This 510(k) Submission

K222056 is an FDA 510(k) clearance for the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on January 26, 2023, 198 days after receiving the submission on July 12, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K222056 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2022
Decision Date January 26, 2023
Days to Decision 198 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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