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FDA 510(k)

SurgTech GENOLL Total Knee System

K-Number: K191192 · 2019-08-01

ApplicantSurgtech, Inc.
Decision Date2019-08-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgTech GENOLL Total Knee System is a medical device manufactured by Surgtech, Inc.. It received FDA 510(k) clearance on 2019-08-01 under approval number K191192. 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 SurgTech GENOLL Total Knee System?

SurgTech GENOLL Total Knee System is a medical device that received FDA 510(k) clearance on 2019-08-01. It is manufactured by Surgtech, Inc.. The 510(k) number is K191192.

When was SurgTech GENOLL Total Knee System approved by the FDA?

SurgTech GENOLL Total Knee System received FDA 510(k) clearance on 2019-08-01, under approval number K191192.

What company makes SurgTech GENOLL Total Knee System?

SurgTech GENOLL Total Knee System is manufactured by Surgtech, Inc..

What is the FDA product code for SurgTech GENOLL Total Knee System?

The FDA product code for SurgTech GENOLL 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 Surgtech, Inc.

K152200SurgTech Interbody System K162125MALUC™ Total Hip Arthroplasty System K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation System K161894SurgTech Trauma System K173455SurgTech Bipolar Head System

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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