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FDA 510(k)

Zimmer Knee Joint Replacement Prostheses MR Labeling

K-Number: K173057 · 2018-03-29

ApplicantZimmer, Inc.
Decision Date2018-03-29
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Knee Joint Replacement Prostheses MR Labeling is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2018-03-29 under approval number K173057. 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 Zimmer Knee Joint Replacement Prostheses MR Labeling?

Zimmer Knee Joint Replacement Prostheses MR Labeling is a medical device that received FDA 510(k) clearance on 2018-03-29. It is manufactured by Zimmer, Inc.. The 510(k) number is K173057.

When was Zimmer Knee Joint Replacement Prostheses MR Labeling approved by the FDA?

Zimmer Knee Joint Replacement Prostheses MR Labeling received FDA 510(k) clearance on 2018-03-29, under approval number K173057.

What company makes Zimmer Knee Joint Replacement Prostheses MR Labeling?

Zimmer Knee Joint Replacement Prostheses MR Labeling is manufactured by Zimmer, Inc..

What is the FDA product code for Zimmer Knee Joint Replacement Prostheses MR Labeling?

The FDA product code for Zimmer Knee Joint Replacement Prostheses MR Labeling is JWH.

Related Clinical Trials

NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06833372 Shock Waves in Knee Arthritis RECRUITING NCT07569549 Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy NOT_YET_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING NCT05488093 Evaluation of Mobility in Subjects With Severe Knee Osteoarthritis Who Are to Undergo Total Knee Replacement RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Zimmer, Inc.

K161830Zimmer M/L Taper Hip Prosthesis K151716Cable-Ready Cable Grip System: Cable-Ready Bone Plate System K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid K172114Zimmer Natural Nail System K181761Zimmer Biomet Select Ceramic Heads

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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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