Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K222056 · 2023-01-26

ApplicantHowmedica Osteonics Corp., Dba Stryker Orthopaedics
Decision Date2023-01-26
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K222056. 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?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee is a medical device that received FDA 510(k) clearance on 2023-01-26. The listed applicant is Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The 510(k) number is K222056.

When did Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee receive FDA 510(k) clearance?

Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee received FDA 510(k) clearance on 2023-01-26, under 510(k) number K222056.

Who is the listed applicant for Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee?

The FDA 510(k) record lists Howmedica Osteonics Corp., Dba Stryker Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07516145Robotic Transjugular Transcatheter Tricuspid Valve ReplacementRECRUITINGNCT07773480Formative Evaluation of a Mobile Application Facilitated Self-directed Rehabilitation Programme for Knee OsteoarthritisNOT_YET_RECRUITING

Other records listing Howmedica Osteonics Corp., Dba Stryker Orthopaedics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemK261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentK253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertK252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperK252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsK251665Triathlon® Hinge Knee System

View all 27 devices →

Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.

↑