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)

Arthrex Eclipse Shoulder Prosthesis System

K-Number: K201542 · 2020-07-08

ApplicantArthrex, Inc.
Decision Date2020-07-08
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Eclipse Shoulder Prosthesis System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-07-08 under approval number K201542. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex Eclipse Shoulder Prosthesis System?

Arthrex Eclipse Shoulder Prosthesis System is a medical device that received FDA 510(k) clearance on 2020-07-08. It is manufactured by Arthrex, Inc.. The 510(k) number is K201542.

When was Arthrex Eclipse Shoulder Prosthesis System approved by the FDA?

Arthrex Eclipse Shoulder Prosthesis System received FDA 510(k) clearance on 2020-07-08, under approval number K201542.

What company makes Arthrex Eclipse Shoulder Prosthesis System?

Arthrex Eclipse Shoulder Prosthesis System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex Eclipse Shoulder Prosthesis System?

The FDA product code for Arthrex Eclipse Shoulder Prosthesis System is PKC.

Related Clinical Trials

NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT05505513 Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback? RECRUITING NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT02525601 Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Cruciate Retaining - Cemented vs. Uncemented ACTIVE_NOT_RECRUITING NCT05124652 An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026)

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

View all 168 devices →

Related Devices (Code: PKC)

K171858Sidus Stem-Free ShoulderZimmer GmbH K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc. K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.

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.

↑