FDA 510(k)

JOURNEY II Unicompartmental Knee System

K-Number: K191211 · 2019-07-25

Decision Date2019-07-25

Product CodeHSX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

JOURNEY II Unicompartmental Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2019-07-25 under 510(k) number K191211. The device is classified under product code HSX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOURNEY II Unicompartmental Knee System?

JOURNEY II Unicompartmental Knee System is a medical device that received FDA 510(k) clearance on 2019-07-25. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K191211.

When did JOURNEY II Unicompartmental Knee System receive FDA 510(k) clearance?

JOURNEY II Unicompartmental Knee System received FDA 510(k) clearance on 2019-07-25, under 510(k) number K191211.

Who is the listed applicant for JOURNEY II Unicompartmental Knee System?

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

What is the FDA product code for JOURNEY II Unicompartmental Knee System?

The FDA product code for JOURNEY II Unicompartmental Knee System is HSX.

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.

NCT02440672JOURNEY™ II CR Total Knee SystemACTIVE_NOT_RECRUITING NCT03247023Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint ReplacementTERMINATED NCT03985839Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and HipCOMPLETED NCT04325022Safety and Effectiveness Study of OR3O™ Dual Mobility System in THAACTIVE_NOT_RECRUITING NCT04849884To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.COMPLETED NCT05444465Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness TearsRECRUITING

Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: HSX)

K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.K251834Persona Partial KneeZimmer Biomet K251618MOTO Partial Knee System ExtensionMedacta International S.A.K251453Arthrex iBalance Partial Knee SystemArthrex, Inc.K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.