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FDA 510(k)

Anatomical Shoulder System

K-Number: K193099 · 2020-01-29

ApplicantZimmer GmbH
Decision Date2020-01-29
Product CodePHX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Anatomical Shoulder System is a medical device manufactured by Zimmer GmbH. It received FDA 510(k) clearance on 2020-01-29 under approval number K193099. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Anatomical Shoulder System?

Anatomical Shoulder System is a medical device that received FDA 510(k) clearance on 2020-01-29. It is manufactured by Zimmer GmbH. The 510(k) number is K193099.

When was Anatomical Shoulder System approved by the FDA?

Anatomical Shoulder System received FDA 510(k) clearance on 2020-01-29, under approval number K193099.

What company makes Anatomical Shoulder System?

Anatomical Shoulder System is manufactured by Zimmer GmbH.

What is the FDA product code for Anatomical Shoulder System?

The FDA product code for Anatomical Shoulder System is PHX.

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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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Zimmer GmbH

K161620Anatomical Shoulder Domelock Dome centric K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System K171858Sidus Stem-Free Shoulder K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System K170072Fitmore® Hip Stem

View all 19 devices →

Related Devices (Code: PHX)

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation K152754COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp K152966Aequalis Fx2Tornier S.A.S. K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P. K170414Arthrex Univers Revers Apex Humeral StemsArthrex, 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.

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