FDA 510(k)

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System

K-Number: K222653 · 2022-10-28

Decision Date2022-10-28

Product CodeNJD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

JOURNEY II UK™ and ENGAGE™ Cementless Partial 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 2022-10-28 under 510(k) number K222653. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System?

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Smith+Nephew, Inc.. The 510(k) number is K222653.

When did JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System receive FDA 510(k) clearance?

JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K222653.

Who is the listed applicant for JOURNEY II UK™ and ENGAGE™ Cementless Partial 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 UK™ and ENGAGE™ Cementless Partial Knee System?

The FDA product code for JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System is NJD.

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: NJD)

K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion K242307ACHIEVE Partial Knee SystemIgnite Orthomotion K190439Engage™ Partial Knee SystemEngage Uni, LLC

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.