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FDA 510(k)

GMK Total Knee System - TiNbN Coating

K-Number: K202684 · 2020-12-11

ApplicantMedacta International S.A.
Decision Date2020-12-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK Total Knee System - TiNbN Coating is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-12-11 under approval number K202684. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK Total Knee System - TiNbN Coating?

GMK Total Knee System - TiNbN Coating is a medical device that received FDA 510(k) clearance on 2020-12-11. It is manufactured by Medacta International S.A.. The 510(k) number is K202684.

When was GMK Total Knee System - TiNbN Coating approved by the FDA?

GMK Total Knee System - TiNbN Coating received FDA 510(k) clearance on 2020-12-11, under approval number K202684.

What company makes GMK Total Knee System - TiNbN Coating?

GMK Total Knee System - TiNbN Coating is manufactured by Medacta International S.A..

What is the FDA product code for GMK Total Knee System - TiNbN Coating?

The FDA product code for GMK Total Knee System - TiNbN Coating is JWH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

View all 146 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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