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FDA 510(k)

GENflex2 Total Knee System

K-Number: K162222 · 2016-09-07

ApplicantStelkast, Inc.
Decision Date2016-09-07
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENflex2 Total Knee System is a medical device manufactured by Stelkast, Inc.. It received FDA 510(k) clearance on 2016-09-07 under approval number K162222. 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 GENflex2 Total Knee System?

GENflex2 Total Knee System is a medical device that received FDA 510(k) clearance on 2016-09-07. It is manufactured by Stelkast, Inc.. The 510(k) number is K162222.

When was GENflex2 Total Knee System approved by the FDA?

GENflex2 Total Knee System received FDA 510(k) clearance on 2016-09-07, under approval number K162222.

What company makes GENflex2 Total Knee System?

GENflex2 Total Knee System is manufactured by Stelkast, Inc..

What is the FDA product code for GENflex2 Total Knee System?

The FDA product code for GENflex2 Total Knee System 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: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Stelkast, Inc.

K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert K190276Provident II Hip Stem

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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