Cleared Traditional

Modular Rotating Hinge Knee Systems and Compatible Components

K223069 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic
Apr 2023
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K223069 is an FDA 510(k) clearance for the Modular Rotating Hinge Knee Systems and Compatible Components, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on April 21, 2023, 203 days after receiving the submission on September 30, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K223069 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date April 21, 2023
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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