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FDA 510(k)

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert

K-Number: K173875 · 2018-01-19

ApplicantStelkast, Inc.
Decision Date2018-01-19
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast, Inc.. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173875. 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 - Ultra-Congruent CR Tibial Insert?

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Stelkast, Inc.. The 510(k) number is K173875.

When did GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert receive FDA 510(k) clearance?

GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173875.

Who is the listed applicant for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert?

The FDA 510(k) record lists Stelkast, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert?

The FDA product code for GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert is JWH.

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.

NCT07544264Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial ComponentRECRUITING

Other records listing Stelkast, Inc. 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.

K190276Provident II Hip StemK162222GENflex2 Total Knee System

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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