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FDA 510(k)

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

K-Number: K241716 · 2024-08-02

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2024-08-02
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is a medical device manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2024-08-02 under approval number K241716. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K241716.

When was Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component approved by the FDA?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component received FDA 510(k) clearance on 2024-08-02, under approval number K241716.

What company makes Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics.

What is the FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component?

The FDA product code for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component is JDI.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06578104 PULSED AF Post-Approval Study RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING

Related PubMed Literature

PMID: 40775863 Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship. Studies in health technology and informatics (2025)

Other Devices by Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K202016Dall-Miles® Cable System K201343Triathlon Total KneeSystem K213129Restoration Modular 115mm Conical Distal Stem K211303Avon Patello-femoral Joint Prosthesis K222632UHR Bipolar Implants, Restoration GAP II Implants K220376Acetabular Dome Hole Plug

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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