Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JOURNEY II XR Knee Instruments

K-Number: K173331 · 2017-11-16

ApplicantSmith & Nephew, Inc.
Decision Date2017-11-16
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JOURNEY II XR Knee Instruments is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2017-11-16 under approval number K173331. 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 JOURNEY II XR Knee Instruments?

JOURNEY II XR Knee Instruments is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K173331.

When was JOURNEY II XR Knee Instruments approved by the FDA?

JOURNEY II XR Knee Instruments received FDA 510(k) clearance on 2017-11-16, under approval number K173331.

What company makes JOURNEY II XR Knee Instruments?

JOURNEY II XR Knee Instruments is manufactured by Smith & Nephew, Inc..

What is the FDA product code for JOURNEY II XR Knee Instruments?

The FDA product code for JOURNEY II XR Knee Instruments is JWH.

Other Devices by Smith & Nephew, Inc.

K163086VLP MINI-MOD 2.0mm Column Plates K161233OXINIUM DH Fermoral Heads K161264TRIGEN Low Profile Bone Screws K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device K162078EVOS Small Fragment Plating System K160923REDAPT Anteverted Cemented Liner

View all 107 devices →

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.

↑